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Background Maternal immunisation to boost respiratory syncytial virus (RSV) specific antibodies in pregnant women is a strategy to enhance infant protection. The timing of maternal vaccination during pregnancy may be critical for its effectiveness. However, Kenya has no documented published data on gestational age distribution of pregnant women attending antenatal care (ANC), or the proportion of women attending ANC during the proposed window period for vaccination, to inform appropriate timing for delivery or estimate potential uptake of this vaccine. Methods A cross-sectional survey was conducted within the Kilifi Health and Demographic Surveillance System (KHDSS), coastal Kenya. A simple random sample of 1000 women who had registered pregnant in 2017 to 2018 and with a birth outcome by the time of data collection was taken. The selected women were followed at their homes, and individually written informed consent was obtained. Records of their antenatal attendance during pregnancy were abstracted from their ANC booklet. The proportion of all pregnant women from KHDSS (55%) who attended for one or more ANC in 2018 was used to estimate vaccine coverage. Results Of the 1000 women selected, 935 were traced with 607/935 (64.9%) available for interview, among whom 470/607 (77.4%) had antenatal care booklets. The median maternal age during pregnancy was 28.6 years. The median (interquartile range) gestational age in weeks at the first to fifth ANC attendance was 26 (21–28), 29 (26–32), 32 (28–34), 34 (32–36) and 36 (34–38), respectively. The proportion of women attending for ANC during a gestational age window for vaccination of 28–32 weeks (recommended), 26–33 weeks and 24–36 weeks was 76.6% (360/470), 84.5% (397/470) and 96.2% (452/470), respectively. Estimated vaccine coverage was 42.1, 46.5 and 52.9% within the narrow, wide and wider gestational age windows, respectively. Conclusions In a random sample of pregnant women from Kilifi HDSS, Coastal Kenya with card-confirmed ANC clinic attendance, 76.6% would be reached for maternal RSV vaccination within the gestational age window of 28–32 weeks. Widening the vaccination window (26–33 weeks) or (24–36 weeks) would not dramatically increase vaccine coverage and would require consideration of antibody kinetics data that could affect vaccine efficacy.

Introduction Oral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15–24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs. Methods We estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH). Results For the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario). Conclusions Using data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.

Successful scale-up of PrEP for HIV prevention in African adolescent girls and young women (AGYW) requires integration of PrEP into young women’s everyday lives. We conducted interviews and focus group discussions with 137 AGYW PrEP users aged 16–25 from South Africa and Kenya. Individual and relational enablers and disablers were explored at key moments during their PrEP-user journey from awareness, initiation and early use through persistence, including PrEP pauses, restarts, and discontinuation. PrEP uptake was facilitated when offered as part of an integrated sexual reproductive health service, but hampered by low awareness, stigma and misconceptions about PrEP in the community. Daily pill-taking was challenging for AGYW due to individual, relational and structural factors and PrEP interruptions (intended or unintended) were described as part of AGYW’s PrEP-user journey. Disclosure, social support, adolescent-friendly health counseling, and convenient access to PrEP were reported as key enablers for PrEP persistence.

Background: Globally, women have higher herpes simplex type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of certain contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM). Methods: Within a randomized trial of the effect of three contraceptive methods – DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant – on HIV acquisition, we assessed HSV-2 acquisition. We followed women who were HSV-2 and HIV seronegative, aged 16-35 years, and seeking effective contraception for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015-2018. HSV-2 serologic testing was done at enrollment and final study visits according to a standardized algorithm. Intention–to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method. Findings: At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI] 0.65-0.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI 0.71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI 0.89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55, 95% CI 2.78-4.48). Interpretation: In a randomized trial, DMPA-IM was not associated with increased risk of HSV-2 acquisition. HSV-2 incidence was >10% per year, emphasizing the need for development of novel HSV-2 prevention strategies for African women. Clinical Trial Registration Details: ClinicalTrials.gov number NCT02550067. Funding Information: The ECHO Trial was made possible by the combined generous support of the Bill & Melinda Gates Foundation, the American people through the United States Agency for International Development and the President’s Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency as part of the EDCTP2 programme supported by the European Union, the South African Medical Research Council, and the United Nations Population Fund. Contraceptive supplies were donated by the Government of South Africa and United States Agency for International Development. Additional funding for testing for herpes simplex type 2 infection was provided in part by the US Centers for Disease Control and Prevention (U48 DP 005013 SIP 14-023) and the University of Washington/Fred Hutch Center for AIDS Research (US National Institutes of Health P30 AI057757). Declaration of Interests: None. Ethics Approval Statement: Ethics review committees at each study site approved the study protocol. All participants provided written informed consent, which included counseling about randomization, each study contraceptive method, and their rights as research participants.

Background Additional progress towards HIV epidemic control requires understanding who remains at risk of HIV infection in the context of high uptake of universal testing and treatment (UTT). We sought to characterize seroconverters and risk factors in the SEARCH UTT trial (NCT01864603), which achieved high uptake of universal HIV testing and ART coverage in 32 communities of adults (≥15 years) in rural Uganda and Kenya. Methods In a pooled cohort of 117,114 individuals with baseline HIV negative test results, we described those who seroconverted within 3 years, calculated gender-specific HIV incidence rates, evaluated adjusted risk ratios (aRR) for seroconversion using multivariable targeted maximum likelihood estimation, and assessed potential infection sources based on self-report. Results Of 704 seroconverters, 63% were women. Young (15–24 years) men comprised a larger proportion of seroconverters in Western Uganda (18%) than Eastern Uganda (6%) or Kenya (10%). After adjustment for other risk factors, men who were mobile [≥1 month of prior year living outside community] (aRR:1.68; 95%CI:1.09,2.60) or who HIV tested at home vs. health fair (aRR:2.44; 95%CI:1.89,3.23) were more likely to seroconvert. Women who were aged ≤24 years (aRR:1.91; 95%CI:1.27,2.90), mobile (aRR:1.49; 95%CI:1.04,2.11), or reported a prior HIV test (aRR:1.34; 95%CI:1.06,1.70), or alcohol use (aRR:2.07; 95%CI:1.34,3.22) were more likely to seroconvert. Among survey responders (N = 607, 86%), suspected infection source was more likely for women than men to be ≥10 years older (28% versus 8%) or a spouse (51% vs. 31%) and less likely to be transactional sex (10% versus 16%). Conclusion In the context of universal testing and treatment, additional strategies tailored to regional variability are needed to address HIV infection risks of young women, alcohol users, mobile populations, and those engaged in transactional sex to further reduce HIV incidence rates.

Author(s): Ayieko, James; Petersen, Maya L; Kabami, Jane; Mwangwa, Florence; Opel, Fred; Nyabuti, Marilyn; Charlebois, Edwin D; Peng, James; Koss, Catherine A; Balzer, Laura B; Chamie, Gabriel; Bukusi, Elizabeth A; Kamya, Moses R; Havlir, Diane V | Abstract: IntroductionAntiretroviral-based HIV prevention, including pre-exposure prophylaxis (PrEP), is expanding in generalized epidemic settings, but additional prevention options are needed for individuals with periodic, high-risk sexual exposures. Non-occupational post-exposure prophylaxis (PEP) is recommended in global guidelines. However, in Africa, awareness of and access to PEP for sexual exposures are limited. We assessed feasibility, acceptability, uptake and adherence in a pilot study of a patient-centred PEP programme with options for facility- or community-based service delivery.MethodsAfter population-level HIV testing with universal access to PrEP for persons at elevated HIV risk (SEARCH Trial:NCT01864603), we conducted a pilot PEP study in five rural communities in Kenya and Uganda between December 2018 and May 2019. We assessed barriers to PEP in the population and implemented an intervention to address these barriers, building on existing in-country PEP protocols. We used community leaders for sensitization. Test kits and medications were acquired through the Ministry of Health supply chain and healthcare providers based at the Ministry of Health clinics were trained on PEP delivery. Additional intervention components were (a)PEP availability seven days/week, (b)PEP hotline staffed by providers and (c)option for out-of-facility medication delivery. We assessed implementation using the Proctor framework and measured seroconversions via repeat HIV testing. Successful "PEP completion" was defined as self-reported adherence over four weeks of therapy with post-PEP HIV testing.ResultsCommunity leaders were able to sensitize and mobilize for PEP. The Ministry of Health supplied test kits and PEP medications; after training, healthcare providers delivered the 28-day regimen with high completion rates. Among 124 persons who sought PEP, 66% were female, 24% were ≤25nyears and 42% were fisherfolk. Of these, 20% reported exposure with a serodifferent partner, 72% with a new or existing relationship and 7% from transactional sex. 12% of all visits were conducted at out-of-facility community-based sites; 35% of participants had ≥1 out-of-facility visit. No serious adverse events were reported. Overall, 85% met the definition of PEP completion. There were no HIV seroconversions.ConclusionsAmong individuals with elevated-risk exposures in rural East African communities, patient-centred PEP was feasible, acceptable and provides a promising addition to the current prevention toolkit.

Supplemental Digital Content is Available in the Text., Background: HIV differentiated service delivery (DSD) models are scaling up in resource-limited settings for stable patients; less is known about DSD outcomes for patients with viremia. We evaluated the effect on viral suppression (VS) of a streamlined care DSD model implemented in the SEARCH randomized universal test and treat trial in rural Uganda and Kenya (NCT:01864603). Methods: We included HIV-infected adults at baseline (2013) who were country guideline antiretroviral therapy (ART) eligible (prior ART experience or CD4 ≤ 350) with ≥1 HIV clinic visit between 2013 and 2017 in SEARCH communities randomized to intervention (N = 16) or control (N = 16). We assessed the effect of streamlined care in intervention community clinics (patient-centered care, increased appointment spacing, improved clinic access, reminders, and tracking) on VS at 3 years. Analysis was stratified by the baseline care status: ART-experienced with viremia, ART-naïve with CD4 ≤ 350, or ART-experienced with VS. Results: Among 6190 ART-eligible persons in care, year 3 VS was 90% in intervention and 87% in control arms (RR 1.03, 95% CI: 1.01 to 1.06). Among ART-experienced persons with baseline viremia, streamlined care was associated with higher VS (67% vs 47%, RR 1.41, 95% CI: 1.05 to 1.91). Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95% CI: 0.95 to 1.16). Among ART-experienced persons with baseline VS, nearly all remained virally suppressed in both arms (97% vs 95%, RR 1.01, 95% CI: 1.00 to 1.03). Conclusions: Streamlined care was associated with higher viral suppression among ART-experienced patients with viremia in this randomized evaluation of ART-eligible patients who were in care after universal HIV testing.

Background Hypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda. Methods and findings This is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure, Matthew Hickey and co-workers report on outcomes of the SEARCH trial of hypertension screening and care in sub-Saharan Africa., Author summary Why was this study done? There is a growing burden of hypertension and resultant cardiovascular disease (CVD) globally, and particularly in sub-Saharan Africa (SSA). Maintenance of normal blood pressure through treatment with antihypertensive medications clearly reduces CVD morbidity and mortality; yet across SSA, only 28% are aware of their hypertension diagnosis, only 18% are on treatment, and only 7% have controlled blood pressure. The HIV chronic care system offers a platform for integrating noncommunicable disease (NCD) care for both people with HIV and the general population, though there are limited data on the implementation and effectiveness of such care models. What did the researchers do and find? We conducted a secondary analysis of data from the SEARCH cluster randomized controlled trial in 32 communities in Kenya and Uganda where all communities received population-wide hypertension and multidisease screening and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Among 86,078 nonpregnant adults screened at baseline, we identified 10,928 (13%) with uncontrolled hypertension, all of whom were referred to the nearest government-run health facility for hypertension care. We conducted comprehensive vital status assessment after 3 years, determining vital status for 99% of participants. Among adults with baseline uncontrolled hypertension, all-cause mortality was 21% lower in intervention compared to control communities (3.1% versus 4.2%). What do these findings mean? Providing hypertension care through an integrated, patient-centered chronic care model was associated with a 21% reduction in all-cause mortality over 3 years among patients with uncontrolled hypertension at study baseline. Though the intervention was associated with improved hypertension control, half of participants remained uncontrolled, attenuating the benefits of hypertension treatment. Strategies to improve linkage and engagement in hypertension care are likely to further improve treatment outcomes in the context of integrated patient-centered hypertension care models. Leveraging the HIV care platform is a promising strategy for delivering chronic hypertension and other NCD care to address the growing burden of NCDs in SSA.

Introduction In Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya. Methods In January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions. Results Stakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting. Conclusions PrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.

Summary Background As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment. Methods We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. Findings 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012). Interpretation On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women. Funding Bill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund.

Women who have a prevention mindset may opt for concurrent use of oral pre-exposure prophylaxis (PrEP) and all forms of contraception; we therefore assessed how contraception may influence PrEP use or vice versa. We analyzed data from Kenyan and Ugandan HIV-uninfected non-pregnant women in sero-discordant partnerships who were participating in the Partners Demonstration Project. Using multivariable generalized estimating equation models, we estimated the associations between effective contraceptive use and 1) PrEP dispensation 2) high effective PrEP use. Among the 311 women (93.1% of all those followed in the Partners Demonstration Project) median age was 29 years (interquartile range [IQR] 24.0–35.0) and 115 (37.0%) reported using effective contraception at baseline. All the women initiated PrEP during the study and moderately high PrEP adherence was recorded at 73.1% of visits over an average 7.5 months following PrEP dispensation. Women (14.8%) consistently used an effective contraceptive throughout study follow-up. PrEP dispensation was more frequent among those concurrently using effective contraception, (adjusted relative risk [aRR] = 1.19; 95% confidence interval [CI] = 1.08–1.32) and contraceptive use was more common among those on PrEP (aRR = 1.63; 95% CI = 1.18–2.25). Among East African women at high risk of HIV infection, PrEP dispensation was more frequent among women using effective contraception, indicating that family planning outlets may be efficient locations to deliver PrEP.

Background Preexposure prophylaxis (PrEP) discontinuation rates in clinical trials and demonstration projects have been well characterized; however, little is known about discontinuation in routine public health settings in sub-Saharan Africa. Understanding discontinuation in nonstudy settings is important for establishing expectations for PrEP continuation in national programs and for facilitating effective PrEP scale-up. Methods We conducted in-depth interviews with 46 individuals who had initiated PrEP at 25 HIV comprehensive care clinics (CCCs) in central and western Kenya and whose clinic records indicated they had discontinued. Results Many of our study participants discontinued PrEP when their perceived risk decreased (eg, hiatus or end of a sexual relationship or partner known to be living with HIV became virally suppressed). Others reported discontinuation due to side effects, daily pill burden, preference for condoms, or their partner's insistence. Participant narratives frequently described facility level factors such as stigma-related discomforts with accessing PrEP at CCCs, inconvenient clinic location or operating hours, long wait times, and short refill dates as discouraging factors, suggesting actionable areas for improving PrEP access and continuation. Conclusion Clients frequently make intentional decisions to discontinue PrEP as they weigh different prevention options within the context of complex lives. Many clients will decide to discontinue PrEP when perceiving themselves to be at reduced risk and PrEP counseling must include provisions for addressing seasons of risk. PrEP will not be the right prevention method for everyone, or forever. Expanding PrEP access points and increasing sex-positive messaging may facilitate PrEP being a better option for many.

Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739. Registered on May 9, 2018

Summary Background Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition. However, adherence among young women (aged 18–24 years) has been challenging. SMS reminders have been shown to improve adherence to antiretroviral therapy in some contexts, including in combination with real-time adherence monitoring. We aimed to determine the effect of SMS reminders on PrEP adherence among young women in Kenya over a 2-year period. Methods The monitoring PrEP among young adult women (MPYA) study was an open label randomised controlled trial involving young adult women at high risk of HIV in Thika and Kisumu, Kenya. Participants were recruited from colleges, vocational institutions, informal settlements, and community-based organisations supporting young women. Women had to be aged 18–24 years and at high risk of HIV acquisition (defined as a VOICE risk score of 5 or higher, or being in a serodiscordant relationship). Study staff randomly assigned participants (1:1) to receive either SMS reminders (SMS reminder group) or no reminders (no SMS reminder group). Study group assignment was known to trial staff but masked to investigators. Reminders were initially sent daily and participants could switch to as-needed reminders (ie, sent only if they missed opening the monitor as expected) after 1 month. Study visits occurred at 1 month, 3 months, and then quarterly (ie, every 3 months). The primary outcome was PrEP adherence over 24 months measured with a real-time electronic monitor and assessed by negative binomial models adjusted for the study site and quarter among participants who collected PrEP. This trial is registered with ClinicalTrials.gov , NCT02915367 . Findings Of 642 women initially approached, 348 eligible women were enrolled between Dec 21, 2016, and Feb 5, 2018. Participants were randomly assigned to either the SMS reminder group (n=173) or the no SMS reminder group (n=175). The median age was 21 years (IQR 19–22) and 228 (66%) of the 348 participants reported condomless sex in the month before baseline. 24 (14%) of the 173 participants assigned to receive daily SMS reminders later opted for as-needed reminders. 69 291 (97%) of 71 791 SMS reminders were sent as planned. Among participants collecting PrEP (thus potentially suggesting a desire for HIV protection), electronically monitored adherence averaged 26·8% over 24 months and was similar by study group (27·0% with SMS, 26·6% without SMS, adjusted incidence rate ratio 1·16 [95% CI 0·93–1·45], p=0·19). There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use. Interpretation SMS reminders were ineffective in promoting PrEP adherence among young Kenyan women. Given the overall low adherence in the trial, additional interventions are needed to support PrEP use in this population. Funding US National Institute of Mental Health.

HIV risk perception may influence the use of HIV prevention interventions. Using data from HIV-negative adults enrolled in a study of pre-exposure prophylaxis (PrEP) and antiretroviral therapy for HIV-serodiscordant couples in Kenya and Uganda, we examined associations between: (1) condom use and risk perception and (2) risk perception and PrEP adherence. Two-thirds of HIV-negative partners reported condomless sex with their HIV-positive partner or another partner in the month prior to study enrollment. Compared to those who reported no condomless sex, participants who reported condomless sex during the month prior to study visit had fivefold higher odds of reporting “high risk” vs “no risk” perception (36.3 versus 10.9%: aOR 4.9, 95% CI 3.4–6.9). Reporting condomless sex in the most recent sex act was associated with increased odds of perceiving some HIV risk (aOR for high risk = 7.3, 95% CI 4.9–10.8; aOR for moderate risk = 4.8, 95% CI 3.5–6.7; aOR for low risk = 3.5, 95% CI 2.7–4.6). We found no significant association between risk perception and PrEP adherence. Sexual behavior aligned with perceived HIV risk, which can facilitate an HIV-negative individual’s decisions about PrEP use.

Pregnancy is a time of heightened HIV risk, but also a phase when a couple can prioritize family health. We conducted secondary analysis of a home-based intervention in rural Kenya to explore couple-level adherence to HIV prevention behaviors. The intervention included health education, relationship-building skills, and Couples HIV Testing and Counseling. Pregnant women were randomized to the intervention (n = 64) or standard care (n = 63) along with male partners. Of 96 couples, 82 (85.0%) were followed to 3 months postpartum, when 31.0% of couples reported perfect adherence to HIV prevention. In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01–9.32). A structural equation model found the intervention had moderate effects on couple communication, large effects on couple efficacy to take action around HIV, which in turn improved HIV prevention behaviors (CFI = 0.969; TLI = 0.955; RMSEA = 0.049). Strengthening couple communication and efficacy may help prevent the spread of HIV to infants or partners around the time of pregnancy.

OBJECTIVE(S) We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV. DESIGN A community cluster randomized trial. METHODS The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA

Few studies have sought to understand factors influencing uptake and continuation of pre-exposure prophylaxis (PrEP) among young adults in sub-Saharan Africa in the context of population-based delivery of open-label PrEP. To address this gap, this qualitative study was implemented within the SEARCH study (NCT#01864603) in Kenya and Uganda, which achieved near-universal HIV testing, and offered PrEP in16 intervention communitiesbeginning in 2016-2017. Focus group discussions (8 groups, n = 88 participants) and in-depth interviews (n = 23) with young adults who initiated or declined PrEP were conducted in five communities, to explore PrEP-related beliefs and attitudes, HIV risk perceptions, motivations for uptake and continuation, and experiences. Grounded theoretical methods were used to analyze data. Young people felt personally vulnerable to HIV, but perceived the severity of HIV to be low, due to the success of antiretroviral therapy (ART): daily pill-taking was more threatening than the disease itself. Motivations for PrEP were highly gendered: young men viewed PrEP as a vehicle for safely pursuing multiple partners, while young women saw PrEP as a means to control risks in the context of engagement in transactional sex and limited agency to negotiate condom use and partner testing. Rumors, HIV/ART-related stigma, and desire for "proof" of efficacy militated against uptake, and many women required partners' permission to take PrEP. Uptake was motivated by high perceived HIV risk, and beliefs that PrEP use supported life goals. PrEP was often discontinued due to dissolution of partnerships/changing risk, unsupportive partners/peers, or early side effects/pill burden. Despite high perceived risks and interest, PrEP was received with moral ambivalence because of its associations with HIV/ART and stigmatized behaviors. Delivery models that promote youth access, frame messaging on wellness and goals, and foster partner and peer support, may facilitate uptake among young people.

Background HIV-prevalence and incidence is high in many fishing communities around Lake Victoria in East Africa. In these settings, mobility among women is high and may contribute to increased risk of HIV infection and poor access to effective prevention and treatment services. Understanding the nature and patterns of this mobility is important for the design of interventions. We conducted an exploratory study to understand the nature and patterns of women’s mobility to inform the design of HIV intervention trials in fishing communities of Lake Victoria. Methods This was a cross-sectional formative qualitative study conducted in six purposively selected fishing communities in Kenya, Tanzania and Uganda. Potential participants were screened for eligibility on age (18+ years) and having stayed in the fishing community for more than 6 months. We collected data using introductory and focus group discussions, and in-depth interviews with key informants. Data focused on: history and patterns of mobility, migration in and out of fishing communities and the relationship between mobility and HIV infection. Since the interviews and discussions were not audio-recorded, detailed notes were taken and written up into full scripts for analysis. We conducted a thematic analysis using constant comparison analysis. Results Participants reported that women in fishing communities were highly mobile for work-related activities. Overall, we categorized mobility as travels over long and short distances or periods depending on the kind of livelihood activity women were involved in. Participants reported that women often travelled to new places, away from familiar contacts and far from healthcare access. Some women were reported to engage in high risk sexual behaviour and disengaging from HIV care. However, participants reported that women often returned to the fishing communities they considered home, or followed a seasonal pattern of work, which would facilitate contact with service providers. Conclusion Women exhibited circular and seasonal mobility patterns over varying distances and duration away from their home communities. These mobility patterns may limit women’s access to trial/health services and put them at risk of HIV-infection. Interventions should be tailored to take into account mobility patterns of seasonal work observed in this study.

Author(s): Camlin, Carol S; Charlebois, Edwin D; Getahun, Monica; Akatukwasa, Cecilia; Atwine, Frederick; Itiakorit, Harriet; Bakanoma, Robert; Maeri, Irene; Owino, Lawrence; Onyango, Anjeline; Chamie, Gabriel; Clark, Tamara D; Cohen, Craig R; Kwarisiima, Dalsone; Kabami, Jane; Sang, Norton; Kamya, Moses R; Bukusi, Elizabeth A; Petersen, Maya L; V Havlir, Diane | Abstract: IntroductionThe rollout of antiretroviral therapy (ART) has been associated with reductions in HIV-related stigma, but pathways through which this reduction occurs are poorly understood. In the newer context of universal test and treat (UTT) interventions, where rapid diffusion of ART uptake takes place, there is an opportunity to understand the processes through which HIV-related stigma can decline, and how UTT strategies may precipitate more rapid and widespread changes in stigma. This qualitative study sought to evaluate how a UTT intervention influenced changes in beliefs, attitudes and behaviours related to HIV.MethodsLongitudinal qualitative in-depth semi-structured interview data were collected within a community-cluster randomized UTT trial, the Sustainable East Africa Research in Community Health (SEARCH) study, annually over three rounds (2014 to 2016) from two cohorts of adults (nn=n32 community leaders, and nn=n112 community members) in eight rural communities in Uganda and Kenya. Data were inductively analysed to develop new theory for understanding the pathways of stigma decline.ResultsWe present an emergent theoretical model of pathways through which HIV-related stigma may decline: internalized stigma may be reduced by two processes accelerated through the uptake and successful usage of ART: first, a reduced fear of dying and increased optimism for prolonged and healthy years of life; second, a restoration of perceived social value and fulfilment of subjective role expectations via restored physical strength and productivity. Anticipated stigma may be reduced in response to widespread engagement in HIV testing, leading to an increasing number of HIV status disclosures in a community, "normalizing" disclosure and reducing fears. Improvements in the perceived quality of HIV care lead to people living with HIV (PLHIV) seeking care in nearby facilities, seeing other known community members living with HIV, reducing isolation and facilitating opportunities for social support and "solidarity." Finally, enacted stigma may be reduced in response to the community viewing the healthy bodies of PLHIV successfully engaged in treatment, which lessens the fears that trigger enacted stigma; it becomes no longer socially normative to stigmatize PLHIV. This process may be reinforced through public health messaging and anti-discrimination laws.ConclusionsDeclines in HIV-related stigma appear to underway and explained by social processes accelerated by UTT efforts. Widespread implementation of UTT shows promise for reducing multiple dimensions of stigma, which is critical for improving health outcomes among PLHIV.

Introduction Global guidelines emphasize the ethical obligation of investigators to help participants in HIV‐endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre‐exposure prophylaxis (PrEP) has increasingly become part of state‐of‐the‐art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. Methods ECHO was an open‐label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part‐way through the course of the trial, oral PrEP was provided to study participants either off‐site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi‐squared tests or t‐tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. Results PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow‐up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p

Addressing ethical issues through mentorship is key to encouraging scientific integrity and increasing research capacity. Across the global health arena, mentorship requires helping mentees understand and negotiate the regulatory aspects of research—which can substantially differ even between countries with similar resources. Mentorship support spans across the research framework from obtaining ethical approval and ensuring scientific integrity, to determining authorship and disseminating study results—providing multiple opportunities to model ethical behavior for mentees. The power imbalances between the global north and south in accessing funding resources produce further challenges in setting the research agenda and for ensuring equity in the dissemination of research findings. Gender further complicates the aspiration for equity; the proportion of women in high administrative or research positions remains low. This study explores four specific mentoring case scenarios commonly encountered in the global health research field in low- and middle-income institutions.

Poor marital satisfaction is associated with high-risk sexual behavior and HIV transmission. We tested whether a counselor-led couple education and counseling intervention dubbed Waya (paternal aunt) would improve marital satisfaction and reduce HIV risk behavior among married couples in Kisumu County, western Kenya. In a pre-post design, we enrolled 60 heterosexual married couples at high risk for HIV to undergo five 1-h couple education and counseling sessions over 56 days. We collected self-reported data on marital satisfaction, the number of sex partners, and condom use with extramarital partners at pre- and post-intervention visits. We used Wilcoxon and McNemar tests to examine the association of our intervention with marital relationship satisfaction and reduction in HIV risk sexual behavior. The intervention was associated with marital relationship satisfaction score improvement from a median of 5 (interquartile range [IQR], 4-5) to 6 (IQR, 6-7) among men and 4 (IQR, 3-5) to 6 (IQR, 5-6) among women (p .01). The intervention was also associated with reducing HIV risk sexual behaviors depicted by a reduction in the number of sex partners in the past one month and an increase in consistent extramarital condom use. The number of sex partners reduced from a median of 2 (IQR, 1-2) to 1 (IQR, 1-2) and consistent extramarital condom use increased from 4% at baseline to 56% among men. Our intervention was associated with improvements in marital relationship satisfaction and reductions in HIV high-risk behaviors necessary for achieving epidemic control in HIV hotspots such as fishing communities in western Kenya.

While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.Pendant que les gouvernements se concentrent sur les profonds bouleversements que la maladie à coronavirus 2019 (COVID-19) engendre pour l'économie mondiale ainsi que sur l'urgence des recherches qui y sont consacrées, d'autres études sont touchées de plein fouet par la pandémie. Plusieurs travaux de recherche d'importance majeure, sans lien avec la COVID-19, ont considérablement ralenti ou ont été totalement interrompus. Soit en raison des restrictions légales relatives à la COVID-19, soit à cause de problèmes logistiques, opérationnels ou d'effectifs. En ce moment, des milliards de personnes à travers le monde sont soumises à un confinement ou un couvre-feu. Comme la durée de telles mesures restrictives est inconnue et susceptible de changer, de nombreuses études sont actuellement en suspens et le bien-être de dizaines de milliers de participants est menacé. Ces circonstances particulières ont entraîné des défis éthiques complexes, qui requièrent une attention immédiate de la part des promoteurs, chercheurs et organismes de réglementation internationaux. Certains promoteurs et organismes de réglementation ont publié des directives sur la manière de gérer les interruptions de recherches cliniques dues à la COVID-19. Elles offrent un bon point de départ pour négocier les écueils au fil de l'évolution de la pandémie, mais elles ne s'appliquent qu'aux chercheurs financés ou administrés par ces instances. Dans le présent document, nous proposons donc des directives destinées à mieux gérer de telles interruptions, au-delà de ce cadre spécifique. Nous soulignons quelques-uns des effets de la pandémie de COVID-19 sur d'autres projets de recherche en cours qui n'ont aucun rapport avec la maladie, et nous donnons des conseils pratiques sur la manière de garantir le bien-être des participants aux études concernées. Enfin, nous parvenons à la conclusion que les législateurs, promoteurs, chercheurs et organismes de réglementation doivent adopter une approche plus souple, afin d'assurer la sécurité des participants tout en préservant l'intégrité des données et en respectant les bonnes pratiques cliniques.Mientras que los gobiernos se han centrado en la perturbación sin precedentes de la economía global que la enfermedad del coronavirus 2019 (COVID-19) ha causado y en la urgente necesidad de investigar sobre esta enfermedad, otras investigaciones sanitarias se han convertido en víctimas de la pandemia. Las principales actividades de investigación que no están relacionadas con la COVID-19 se han reducido de manera significativa o se han suspendido por completo debido a las restricciones legales relacionadas con la COVID-19 o a los problemas logísticos, de personal u operativos. En la actualidad, el confinamiento o los toques de queda afectan a miles de millones de personas en todo el mundo. Muchos estudios se encuentran ahora en el limbo y el bienestar de decenas de miles de sus participantes está en peligro debido a que se desconoce el calendario de esas medidas restrictivas y está sujeto a cambios. Estas circunstancias han planteado desafíos éticos complejos que merecen una atención urgente por parte de los patrocinadores, los investigadores y los organismos reguladores internacionales. Algunos patrocinadores y organismos reguladores han publicado pautas sobre cómo se deben gestionar las perturbaciones relacionadas con la COVID-19 en la investigación clínica. Aunque estas pautas constituyen un buen punto de partida para hacer frente a los desafíos de la pandemia que está evolucionando, solo se aplican a los investigadores que son financiados o gestionados por estos organismos. En este documento, se ofrecen pautas para gestionar esas perturbaciones que se extienden más allá de estos entornos específicos. Se resaltan algunos de los efectos de la pandemia de la COVID-19 en otros proyectos de investigación en curso que no están relacionados con esta enfermedad y se proporcionan pautas prácticas sobre cómo se debe gestionar el bienestar de los participantes afectados en el estudio. Se concluye que los responsables de formular las políticas, los patrocinadores, los investigadores y los organismos reguladores deben adoptar un enfoque más flexible para garantizar la seguridad de los participantes, al tiempo que se mantiene la integridad de los datos y se cumplen las buenas prácticas clínicas.بينما كانت الحكومات تركز على الاضطراب غير المسبوق في الاقتصاد العالمي والذي نتج عن مرض فيروس كورونا 2019 (كوفيد-19)، والحاجة الملحة للأبحاث حول كوفيد-19، تأثرت الأبحاث الصحية الأخرى نتيجة للوباء. كما تقلصت بشكل كبير عمليات البحث الرئيسية غير المتعلقة بكوفيد-19، أو توقفت بشكل تام نظراً للقيود القانونية، أو المخاوف اللوجستية أو التشغيلية، أو تلك الخاصة بفرق العمل، والمتعلقة بكوفيد-19. يقع مليارات الأشخاص حول العالم حالياً تحت تأثير عمليات الإغلاق أو حظر التجول. نظراً لأن النطاق الزمني لمثل هذه التدابير التقييدية غير معروف، كما أنه عُرضة للتغيير، فإن العديد من الدراسات أصبحت الآن في غياهب النسيان، كما أن عشرات الآلاف من المشاركين في الدراسة معرضين للخطر. طرحت هذه الظروف تحديات أخلاقية معقدة تستحق الاهتمام العاجل من الرعاة والباحثين والمراقبين الدوليين. قامت جهات راعية وجهات رقابية معينة بنشر توجيهات حول كيفية إدارة الاضطرابات في الأبحاث السريرية، والمتعلقة بكوفيد-19. على الرغم من أن هذه التوجيهات توفر نقطة انطلاق جيدة لاستعراض تحديات الوباء المتزايدة، إلا أنها تنطبق فقط على الباحثين الممولين من جانب هذه الهيئات، أو الخاضعين لإدارتها. نحن نقدم هنا توجيهات حول إدارة مثل هذه الاضطرابات التي تسري خارج إطار هذه الظروف المحددة. نحن نسلط الضوء على بعض آثار وباء كوفيد-19 على المشاريع البحثية الجارية الأخرى، والتي لا علاقة لها بكوفيد-19، كما نقدم إرشادات عملية حول كيفية إدارة رفاهية المشاركين في الدراسة. نحن نستنتج أنه يجب على واضعي السياسات والرعاة والباحثين والمراقبين انتهاج أسلوب أكثر مرونة لضمان سلامة المشاركين، إلى جانب الحفاظ على تكامل البيانات والالتزام بالممارسات السريرية الجيدة.由于各国政府一直在关注 2019 冠状病毒病（新型冠状病毒肺炎）对全球经济造成的前所未有的破坏，以及对新型冠状病毒肺炎研究的迫切需求，因此导致其他健康研究成为这场大流行下的牺牲品。与新型冠状病毒肺炎无关的重大研究活动要么因为新冠肺炎相关的法律限制，要么出于后勤、人员配备或运营方面的考虑，都被大幅减少或完全暂停。目前全球有数十亿人受到封城或宵禁的影响。由于这种限制性措施的时间范围尚不清楚，而且随时可能会变化，许多研究现在处于停滞状态，数万名研究参与者的福利得不到保障。这些情况引起了复杂的道德挑战，急需国际赞助商、研究人员和监管机构的高度关注。某些赞助商和监管机构已经发布了关于如何管理由新型冠状病毒肺炎导致的临床研究中断事件的指导方针。虽然这些指导方针为应对不断演变的大流行带来的挑战提供了一个很好的起点，但它们只适用于由这些机构资助或管理的研究人员。在本文中，我们提供了管理此类中断事件的指导方针，这些指导方针不止适用于上述特定状况。我们强调了新型冠状病毒肺炎大流行对其他正在进行的与新型冠状病毒肺炎无关的研究项目造成的影响，并就如何管理受影响的研究参与者的福利提供了实用指导。我们的结论是，政策制定者、赞助商、研究人员和监管机构必须采取更灵活的方法，以确保参与者的安全，同时保持数据完整性，并遵守药品临床管理规范。.В то время как внимание правительств стран приковано к беспрецедентной дестабилизации мировой экономики, вызванной коронавирусным заболеванием 2019 года (COVID-19), и к насущной необходимости проведения исследований вируса COVID-19, другие научные исследования в области здравоохранения отошли на второй план из-за пандемии. Крупные научные исследования, не связанные с COVID-19, были значительно сокращены или полностью приостановлены по причине связанных с COVID-19 правовых ограничений или в результате проблем с логистикой, отсутствия специалистов или по соображениям, связанным с текущей деятельностью. Миллиарды людей во всем мире в настоящее время страдают от введенных режимов самоизоляции или комендантского часа. Поскольку сроки таких ограничительных мер неизвестны и могут изменяться, многие исследования в настоящее время находятся в состоянии неопределенности, а благополучие десятков тысяч участников исследований находится под угрозой. Данные обстоятельства привели к возникновению сложных этических проблем, требующих неотложного внимания со стороны международных спонсоров, исследователей и регулирующих государственных органов. Некоторые спонсоры и регулирующие государственные органы опубликовали рекомендации по управлению непредвиденными изменениями в ходе клинических исследований, вызванными COVID-19. Несмотря на то что такие рекомендации являются отличной отправной точкой для решения проблем, связанных с распространением пандемии, они полезны только тем исследователям, которые финансируются или контролируются этими органами. Авторы приводят руководящие принципы по управлению такими непредвиденными изменениями, которые могут применяться к более широкому набору конкретных условий и обстоятельств. Авторы перечисляют некоторые из последствий пандемии COVID-19 для других текущих исследовательских проектов, не связанных с COVID-19, и дают практические рекомендации по управлению благополучием затронутых участников исследований. Авторы приходят к выводу о том, что органы, отвечающие за формирование политики, спонсоры, исследователи и регулирующие государственные органы должны применять более гибкий подход для обеспечения безопасности участников, сохраняя при этом целостность данных и соблюдая передовые клинические практики.

An estimated 358 million new cases of the four most common curable sexually transmitted infections (STIs) – the three bacterial pathogens, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, plus the parasite Trichomonas vaginalis – are acquired worldwide annually.[1–3] Globally, the burden of STIs is greatest in low- and middle-income countries (LMIC), and the overlapping epidemics of HIV and STIs have been recognized since the earliest days of the HIV epidemic.[3–8] The majority of new HIV infections occur in sub-Saharan Africa,[9] and sexually active African women (particularly those under age 30) face disproportionate HIV risk, accounting for more than half of new infections on that continent, and with incidence rates that are often double their male age-mates.[10–12] The consequences of bacterial STIs on sexual and reproductive health can be significant and long-term through sequelae including pelvic inflammatory disease (PID), chronic pelvic pain, tubal infertility, pregnancy complications, fetal and neonatal death, and heightened susceptibility to HIV.[3, 5, 6, 13, 14] These consequences - physical, psychological, and social - of STIs are overwhelmingly borne by women.[15, 16]

Introduction Sustained HIV viral suppression resulting from antiretroviral therapy (ART) eliminates the risk of HIV transmission, a concept popularly framed as Undetectable = Untransmittable (U = U). We explored knowledge and acceptance of information around the elimination of HIV transmission risk with ART (U = U) in Kenya. Methods Our qualitative study was conducted within a project evaluating the use of pre‐exposure prophylaxis (PrEP) integrated into ART care for HIV serodiscordant couples in public clinics in Kenya (the Partners Scale Up Project). From February 2017 to April 2019, we conducted semi‐structured key informant interviews with 83 health providers and in‐depth interviews with 61 HIV‐negative people in serodiscordant relationships receiving PrEP services. Transcripts were coded using thematic analysis. Results Health providers reported being aware of reduced risk of HIV transmission as a result of consistent ART use and used words such as “very low,” “minimal” and “like zero” to describe HIV transmission risk after viral suppression. Providers reported finding viral load results helpful when counselling clients about the risk of HIV transmission. Many lacked confidence in U = U and counselled on consistent condom use even after viral suppression while some expressed concerns that communicating this message to people living with HIV (PLHIV) would lead them to engage in multiple sexual relationships. Other providers reported that they did not counsel about the reduced risk of HIV transmission after viral suppression for fear of being blamed if HIV transmission occurred. HIV‐negative partners reported being informed about U = U by providers but they did not believe nor trust the message. Even after their partners achieved viral suppression, some HIV‐negative partners were unwilling to stop PrEP, while others indicated that they would use condoms if they stopped PrEP to be sure that they were protected from HIV. Conclusions Despite awareness that effective ART use eliminates HIV transmission risk, there is both a lack of in‐depth knowledge and conviction about the strategy among health providers and HIV‐negative partners in serodiscordant relationships. New strategies that go beyond communicating the science of U = U to consider the local social and clinical environments could maximize the effectiveness of U = U.

Author(s): McDonough, Annie; Weiser, Sheri D; Daniel, Afkera; Weke, Elly; Wekesa, Pauline; Burger, Rachel; Sheira, Lila; Bukusi, Elizabeth A; Cohen, Craig R | Abstract: Background:Food insecurity remains a major obstacle to achieving health and well-being for individuals living with HIV in western Kenya. Studies have shown that pregnant women are vulnerable to experiencing food insecurity worldwide, with significant consequences for both maternal and child health. The Shamba Maisha cluster randomized controlled trial in western Kenya (which means "farming for life" in Swahili) tested the effects of a multisectoral livelihood intervention consisting of agricultural and finance trainings, farm inputs, and a loan on health and food security among 746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties. Objectives:We conducted a qualitative substudy within the Shamba Maisha trial to understand the experiences and perspectives of pregnant women living with HIV enrolled in the trial. Methods:Thirty women who had experienced a pregnancy during the Shamba Maisha study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide. Results:Intervention participants interviewed noted improvements in maternal nutrition compared with previous pregnancies, which they attributed to the livelihood intervention. Key identified pathways to improved nutrition included improved access to vegetables, increased variety of diet through vegetable sales, and improved nutritional awareness. Women in the intervention arm also perceived increased weight gain compared with prior pregnancies and increased strength and energy throughout pregnancy. Conclusions:Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.This trial was registered at clinicaltrials.gov as NCT02815579.

Delivery of oral PrEP, a potent HIV prevention intervention, has begun within public health systems in many countries in Africa. Training as many health providers as possible expeditiously is necessary to efficiently and rapidly scale up PrEP delivery among at risk populations and thereby realize the greatest impact of PrEP. We designed and implemented an innovative on-site modular training approach delivered in five two-hour modules. The modules could be covered in two consecutive days or be broken across several days enabling flexibility to accommodate health provider work schedules. We assessed knowledge gain comparing pre-and post-training test scores and determined monthly PrEP uptake for six months following the training intervention. We also evaluated the cost of this training approach and conducted key informant interviews to explore acceptability among health providers. Between January 2019 and December 2020, 2111 health providers from 104 health facilities were trained on PrEP. Of 1821 (83%) providers who completed both pre- and post-tests, 505 (28%) were nurses, 333 (18%) were HIV counsellors, 276 (15%) were clinical officers and 255 (14%) were lay providers. The mean score prior to and after training was 58% and 82% respectively (p

Kenya introduced universal antiretroviral treatment (ART) for pregnant and breastfeeding women living with HIV (Option B+) in 2014. A retrospective study was conducted to review consecutive records for HIV positive pregnant women presenting for antenatal care (ANC) at five clinics in western Kenya. Known positive women (KP :HIV diagnosis prior to current pregnancy) were compared to newly positive (NP) women regarding virologic suppression and retention in care. Among 165 women included, 71 (43%) NP and 94 (57%) KP, NP were younger (24.5 years (SD 4.6) vs. 28.1 years (SD 5.6) compared to KP (p .001). Almost all NP (97%) were initiated on Option B+ while over half of KP (59%) started ART for clinical/immunological criteria (p .0001). KPs were more likely than NPs to have a VL performed following Kenyan guidelines (64% vs. 31%; p .001). Among those tested, virologic suppression was high in both groups (92% KP vs. 100% NP; p = .31). More KPs (82%) vs. NPs (66%) remained active in care at 15-18 months of follow-up (p = .02). Women newly diagnosed with HIV during pregnancy show poorer uptake of VL testing and worse retention in care than those diagnosed prior to pregnancy.

Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings. The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods. Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration. Registered with ClinicalTrials.gov on February 14, 2017: NCT03052010 .

BACKGROUND Global guidelines recommend preexposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy. METHODS In an open-label delivery study of PrEP integrated with ART for high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and 1-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting. RESULTS Outcomes from 30 women who elected to continue PrEP throughout pregnancy were compared with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant decreases in the frequency of pregnancy loss [16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio (aOR) = 0.59, P = 0.4] and preterm delivery [0 versus 7.7%, (aOR) = 0.54, exact P = 0.6]. No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, P = 0.05) and head circumference (0.24 versus 1.07, P = 0.04) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth. CONCLUSION This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.

Engaging both partners of a pregnant couple can enhance prevention of mother-to-child transmission of HIV and promote family health. We developed and piloted an intervention to promote couple collaboration in health during pregnancy and postpartum in southwestern Kenya. We utilized formative data and stakeholder input to inform development of a home-based couples intervention. Next, we randomized pregnant women to intervention (n = 64) or standard care (n = 63) arms, subsequently contacting their male partners for enrollment. In the intervention arm, lay health workers conducted couple home visits, including health education, couple relationship and communication skills, and offers of couple HIV testing and counseling (CHTC) services. Follow-up questionnaires were conducted 3 months postpartum (n = 114 women, 86 men). Baseline characteristics and health behaviors were examined by study arm using t-tests, chi-square tests, and regression analyses. Of the 127 women randomized, 96 of their partners participated in the study. Of 52 enrolled couples in the intervention arm, 94% completed at least one couple home visit. Over 93% of participants receiving couple home visits were satisfied and no adverse social consequences were reported. At follow-up, intervention couples had a 2.78 relative risk of having participated in CHTC during the study period compared with standard care couples (95% confidence interval: 1.63–4.75), and significant associations were observed in other key perinatal health behaviors. This pilot study revealed that a home-based couples intervention for pregnant women and male partners is acceptable, feasible, and has the potential to enhance CHTC and perinatal health behaviors, leading to improved health outcomes.

Background: Pregnant and postpartum women in high HIV prevalent regions are at increased HIV risk. Oral pre-exposure prophylaxis (PrEP) can decrease HIV incidence reducing infant HIV infections. Understanding healthcare worker (HCW) beliefs about PrEP prior to national roll-out is critical to supporting PrEP scale-up. Methods: We conducted 45 semi-structured interviews among a range of HCW cadres with and without PrEP provision experience purposively recruited from four clinics in Kenya to compare their views on prescribing PrEP during pregnancy and postpartum. Interviews were analysed using a conventional content analysis approach to identify key influences on PrEP acceptability and feasibility. Results: All HCWs perceived PrEP as an acceptable and feasible HIV prevention strategy for pregnant and postpartum women. They believed PrEP meets women’s needs as an on-demand, female-controlled prevention strategy that empowers women to take control of their HIV risk. HCWs highlighted their role in PrEP delivery success while acknowledging how their knowledge gaps, concerns and perceived PrEP implementation challenges may hinder optimal PrEP delivery. Conclusion: HCWs supported PrEP provision to pregnant and postpartum women. However, counseling tools to address risk perceptions in this population and strategies to reduce HCW knowledge gaps, concerns and perceived implementation barriers are required.

OBJECTIVE: To determine the effectiveness of community health campaigns (CHCs) as a strategy for human papillomavirus (HPV)-based cervical cancer screening in rural western Kenya. METHODS: Between January and November 2016, a cluster-randomized trial was carried out in 12 communities in western Kenya to investigate high-risk HPV testing offered via self-collection to women aged 25–65 years in CHCs versus government health facilities. Outcome measures were the total number of women accessing cervical cancer screening and the proportion of HPV-positive women accessing treatment. RESULTS: In total, 4944 women underwent HPV-based cervical cancer screening in CHCs (n=2898) or health facilities (n=2046). Screening uptake as a proportion of total eligible women in the population was greater in communities assigned to CHCs (60.0% vs 37.0%, P

BACKGROUND In rural sub-Saharan Africa (SSA), the human immunodeficiency virus (HIV)/AIDS pandemic has exerted effects on nearly every aspect of life. Yet despite the pandemic's near ubiquitous impacts, major barriers to HIV care, treatment, and support persist. Compounding the barriers to care is the incredible complexity and diversity of experience across different sociocultural contexts. OBJECTIVES This exploratory community-based participatory study aimed to generate an explanatory model about how geographic and socioeconomic marginalization shape community perception of HIV care, treatment, and support among rural communities of Mfangano Island, Kenya. METHODS Twelve focus groups with a total of 105 participants were conducted as a part of a mixed-methods cross-sectional health study. RESULTS Study findings are organized within an ecological framework with the following themes: readiness at the individual level, social capital at the household level, and collective efficacy at the community level. Potential solutions were also described within this framework; enabling encouragement at the individual level, enhancing productivity at the household level, and addressing underlying socioeconomic inequities at the community level. CONCLUSIONS HIV-related consequences at the individual, household, and community levels have adversely affected how Mfangano communities respond to the HIV/AIDS epidemic. Community-based strategies are needed to address interrelated inequities at multiple levels. Changing community perception may overcome HIV stigma to enable individual readiness to seek care. Access to care and treatment enhances productivity and hence social capital in HIV-affected households. Addressing socioeconomic inequities at the community level increases access to social and instrumental support and, thus, may decrease risk and vulnerability for HIV/AIDS.

Rationale A growing body of research emphasizes the need to engage social networks in maternal and child nutrition interventions. However, an understanding of how interventions functionally engage not only mothers but fathers, grandparents, friends, and other social network members remains limited. Objective This study uses an adaptation of a social-ecological model to analyze the multiple levels at which the Kanyakla Nutrition Program operates to change behavior. Methods This study analyzes focus group data (four groups; n = 35, 7 men and 28 women) following the implementation of the Kanyakla Nutrition Program, a novel nutrition intervention engaging social networks to increase nutrition knowledge, shift perceptions, and promote positive practices for infant and young child feeding and community nutrition in general. Results: Participant perspectives indicate that the Kanyakla Nutrition Program contributed to nutrition knowledge and confidence, changed perceptions, and supported infant and child feeding practices at the individual, interpersonal, and institutional levels. However, many respondents report challenges in transcending barriers at the broader community and systems levels of influence, where environmental and economic constraints continue to affect food access. Conclusion Analysis of the Kanyakla Nutrition Program suggests that for interventions addressing household level determinants of nutrition, simultaneously engaging the household's network of interpersonal and community relationships can play a role in building momentum and consensus to address persistent structural barriers to improved nutrition.

Background: Reducing tuberculosis (TB) deaths among children requires a better understanding of the gaps in the care cascade from TB diagnosis to treatment completion. We sought to assess the child TB care cascade in 32 rural communities in Uganda and Kenya using programmatic data. Methods: This is a retrospective cohort study of 160,851 children (agesâ¯

With the planned scale-up of pre-exposure prophylaxis (PrEP) for HIV prevention among serodiscordant couples in resource-limited settings, gaining an understanding of what motivates serodiscordant couples to prevent HIV is critical. We conducted 44 semi-structured, in-depth individual or couple interviews with 63 participants (33 HIV-infected and 30 HIV-uninfected participants) enrolled in a prospective implementation study of oral antiretroviral-based prevention in Kisumu, Kenya. Transcripts were iteratively analysed using inductive content analysis. Findings point to the importance of maintaining the emotional and economic stability of the partnership and family as motivators in preventing HIV transmission. Female participants identified fear of blame or potential violence for transmitting HIV as a motivator. Furthermore, couples primarily held the HIV-infected individual responsible for HIV prevention, but also held women more accountable for the use of prevention methods such as condoms. These themes substantiate traditional gender norms but also reveal how dyadic interdependence challenges these norms. As programmes in resource-limited settings scale up PrEP access, they should simultaneously capitalise on HIV serodiscordant couples' motivations for HIV prevention and address gender norms so women do not find themselves unduly responsible for the prevention of HIV transmission.

Background To explore the association between concomitant hormonal contraceptive and antiretroviral therapy (ART) use and (1) plasma viral suppression and (2) genital HIV shedding among HIV-positive women initiating ART. Methods We analyzed plasma viral load and genital viral RNA shedding from 1079 HIV-positive women initiating ART who were followed prospectively in 3 sub-Saharan African HIV prevention studies. Plasma and endocervical swab samples were collected every 6 months. Self-reported contraceptive use was categorized into injectable, implant, oral, or nonhormonal/no contraception. We used multivariate Cox regression to assess time to plasma viral suppression and logistic regression with generalized estimating equations to assess genital viral shedding for each contraceptive method. Results At the time of ART initiation, there were 211 (20%) injectable, 69 (6%) implant, 50 (5%) oral, and 749 (69%) nonhormonal or no method users. Plasma viral suppression was high (90% by 6 months) and hormonal contraceptives did not diminish time to plasma viral suppression as compared to nonhormonal/no methods [adjusted hazard ratios: injectables 0.89 (95% confidence interval: 0.75 to 1.07), implants 0.91 (0.68 to 1.23), and oral methods 1.33 (1.06 to 1.66)]. Genital viral shedding was uncommon any time after ART initiation (only 9% of samples had detectable viral shedding) and hormonal contraceptives were not associated with an increased detection of genital viral shedding [adjusted odds ratios: injectables 1.07 (0.69 to 1.65), implants 0.67 (0.31 to 1.49), and oral methods 0.56 (0.19 to 1.69)]. Conclusions The hormonal contraceptives assessed were not associated with reduced ART effectiveness among HIV-positive women initiating ART. HIV-positive women should continue to be offered contraceptive options, including hormonal ones that best meet their needs.

E PIDEMIOLOGY High Mobility and HIV Prevalence Among Female Market Traders in East Africa in 2014 AQ : 1 Carol S. Camlin, PhD, MPH,*†‡ Alison M. El Ayadi, ScD,*† Zachary A. Kwena, PhD,§ Willi McFarland, PhD, MPH,‡k Mallory O. Johnson, PhD,‡ Torsten B. Neilands, PhD,‡ Elizabeth A. Bukusi, MBChB, MMed, MPH, PhD,§ and Craig R. Cohen, MD, MPH*† Background: The contribution of women’s mobility to the HIV/ AIDS epidemic in Africa is poorly understood, despite women’s high mobility and evidence that it is associated with higher-risk sexual behavior. We sought to measure levels of mobility, HIV prevalence, and related risk behaviors among female traders in Kisumu, Kenya. Methods: We used global positioning system mapping to develop a probability-based sample and recruited 305 female market traders for participation in a survey and voluntary HIV counseling and testing in 2014. We estimated HIV prevalence and fitted logistic regression models to measure associations between mobility, risk behaviors, and HIV infection. Results: HIV prevalence was 25.6% (95% confidence interval: 21.0 to 30.8); 11.5% had migrated (changed residence, over county, or national boundary) in the past year and 39.3% in the past 5 years. More than one-third (38.3%) spent nights away from main residence in the past month, with 11.4% spending more than a week away. Multiple partners were reported by 13.1% of women in the last year; 16% of married women reported a concurrent partnership. Mobility was not significantly associated with HIV prevalence, although recent short-term mobility was significantly correlated with higher numbers of sexual partners in the past year. Conclusions: Female market traders were highly mobile, and HIV prevalence among traders was higher than in the general population of women of reproductive age in Kisumu (15.3% in 2013), and Received for publication June 24, 2016; accepted November 9, 2016. From the *Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, San Francisco, CA; †Bixby Center for Global Reproductive Health, University of California, San Francisco, San Francisco, CA; ‡Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, CA; §Centre for Microbiology Research, Kenya Medical Research Institute, Kwale, Kenya; and kDepartment of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA. AQ : 2 Supported by a grant from the National Institutes of Health, University of California, San Francisco-Gladstone Institute of Virology & Immunology Center for AIDS Research (UCSF-CFAR), P30-AI027763. C.S.C. was supported by a Research Scientist Development Award from the National Institute of Mental Health (NIMH), K01MH093205. M.O.J. was supported by Grant Number K24DA037034. AQ : 3 The authors have no conflicts of interest to disclose. Correspondence to: Carol S. Camlin, PhD, MPH, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 550 16th Street, 3rd Floor (UCSF Mailcode 1224), San Francisco, CA 94158-2549 (e-mail: carol.camlin@ucsf.edu). Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. Nyanza Province, Kenya (16.1% in 2012). High HIV prevalence and risk behavior among women in this study warrant accelerated attention to HIV prevention and care needs of mobile women, including market traders. Key Words: HIV, migration, mobility, female migrants, East Africa, Kenya (J Acquir Immune Defic Syndr 2016;00:1–8) INTRODUCTION The contribution of population mobility to the HIV epidemic in sub-Saharan Africa is well documented; the spread of HIV followed the corridors of population move- ment. 1–10 However, mobility and HIV research has tended to focus on risks to male labor migrants and their partners, or migrants overall, often failing to measure the risks to women through their direct participation in migration. 3,11–17 Yet across the region, women’s levels of participation in internal migration (ie, changes in residence within national bound- aries) and short-term mobility (frequent travel without a permanent change in residence) have now met or exceeded those of men. 18–22 Moreover, the few studies which have examined HIV risks to female migrants found higher risk behavior and HIV prevalence among migrant compared with nonmigrant women, 23–30 and suggest differential HIV risks associated with mobility for women versus men. 30 The literature on migration has highlighted the cen- trality of sex to understanding migration decision-making, determinants, and consequences. 31–33 Indeed, in Southern and East Africa, mobility patterns differ for men and women, and have important implications for HIV risk; women have tended to migrate shorter distances to informal settlements or regional towns, retaining ties to rural homes and returning frequently, whereas men have migrated over longer distances to urban areas, and have been less likely to return to households of origin. 18,34 Engagement in different corridors of mobility and destinations likely exposes female migrants to sexual networks and geographic areas of different HIV prevalence compared with males, resulting in different probabilities of infection for each given sexual act. 35 Population-based studies report HIV prevalence in informal settlements and periurban areas to be twice as high compared with urban and rural areas. 5,28,36 Thus, high female mobility may contribute to the sustained, high prevalence of HIV in Southern and East Africa, enabling J Acquir Immune Defic Syndr Volume 00, Number 00, Month, 2016 www.jaids.com | Copyright O 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

Objectives Trichomonas vaginalis is the most prevalent curable STI worldwide and has been associated with adverse health outcomes and increased HIV-1 transmission risk. We conducted a cross-sectional analysis among couples to assess how characteristics of both individuals in sexual partnerships are associated with the prevalence of male and female T. vaginalis infection. Methods African HIV-1 serodiscordant heterosexual couples were concurrently tested for trichomoniasis at enrolment into two clinical trials. T. vaginalis testing was by nucleic acid amplification or culture methods. Using Poisson regression with robust standard errors, we identified characteristics associated with trichomoniasis. Results Among 7531 couples tested for trichomoniasis, 981 (13%) couples contained at least one infected partner. The prevalence was 11% (n=857) among women and 4% (n=319) among men, and most infected individuals did not experience signs or symptoms of T. vaginalis . Exploring concordance of T. vaginalis status within sexual partnerships, we observed that 61% (195/319) of T. vaginalis -positive men and 23% (195/857) of T. vaginalis -positive women had a concurrently infected partner. In multivariable analysis, having a T. vaginalis -positive partner was the strongest predictor of infection for women (relative risk (RR) 4.70, 95% CI 4.10 to 5.38) and men (RR 10.09, 95% CI 7.92 to 12.85). For women, having outside sex partners, gonorrhoea, and intermediate or high Nugent scores for bacterial vaginosis were associated with increased risk of trichomoniasis, whereas age 45 years and above, being married, having children and injectable contraceptive use were associated with reduced trichomoniasis risk. Additionally, women whose male partners were circumcised, had more education or earned income had lower risk of trichomoniasis. Conclusions We found that within African HIV-1 serodiscordant heterosexual couples, the prevalence of trichomoniasis was high among partners of T. vaginalis -infected individuals, suggesting that partner services could play an important role identifying additional cases and preventing reinfection. Our results also suggest that male circumcision may reduce the risk of male-to-female T. vaginalis transmission.

Understanding feedbacks between human and environmental health is critical for the millions who cope with recurrent illness and rely directly on natural resources for sustenance. Although studies have examined how environmental degradation exacerbates infectious disease, the effects of human health on our use of the environment remains unexplored. Human illness is often tacitly assumed to reduce human impacts on the environment. By this logic, ill people reduce the time and effort that they put into extractive livelihoods and, thereby, their impact on natural resources. We followed 303 households living on Lake Victoria, Kenya over four time points to examine how illness influenced fishing. Using fixed effect conditional logit models to control for individual-level and time-invariant factors, we analyzed the effect of illness on fishing effort and methods. Illness among individuals who listed fishing as their primary occupation affected their participation in fishing. However, among active fishers, we found limited evidence that illness reduced fishing effort. Instead, ill fishers shifted their fishing methods. When ill, fishers were more likely to use methods that were illegal, destructive, and concentrated in inshore areas but required less travel and energy. Ill fishers were also less likely to fish using legal methods that are physically demanding, require travel to deep waters, and are considered more sustainable. By altering the physical capacity and outlook of fishers, human illness shifted their effort, their engagement with natural resources, and the sustainability of their actions. These findings show a previously unexplored pathway through which poor human health may negatively impact the environment.

To ensure the continuity of high-quality HIV care in Kisumu County, Kenya during the corona virus disease 2019 pandemic, the Ministry of Health implemented a strategy to promote physical distancing and corona virus disease 2019 case detection. A total of 23 262 (84.2%) of the 27 641 patients eligible for early refill received an extra 3-month supply of antiretrovirals. Across 60 Ministry of Health clinics, average attendance decreased from 1298 to 640 patients per day postintervention, representing a 50.7% reduction.

Introduction HIV testing is a required part of delivery of pre‐exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under‐staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility‐based HIV self‐testing (HIVST) among young women using PrEP in an implementation programme. Methods Between February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow‐up visit, women were given the option to choose between provider‐initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST. Results A total of 172 women were offered HIVST at 202 PrEP follow‐up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow‐up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p

Author(s): Gitahi, Nyawira; Camlin, Carol; Mwania, Veronica; Ngure, Kenneth; Auerswald, Colette; Bukusi, Elizabeth | Abstract: BackgroundLittle data is available on the long-term psychosocial effects of disclosure of HIV status that may occur in late adolescence, even when disclosure is timely. Moreover, few studies have described the post-disclosure psychosocial needs of older adolescents who experience delayed disclosure. This study sought to address existing knowledge gaps in the post-disclosure experiences and psychosocial needs of older adolescents living with HIV (ALWHIV).MethodsWe conducted focus group discussions (FGDs) and in-depth interviews (IDIs) among older perinatally infected adolescents aged 16-19 years We collected socio-demographic data and baseline viral load (copies/ml) results for the preceding six months using interviewer-administered questionnaires and clinical notes abstraction. We analysed data inductively and deductively to identify themes related to the experiences and expectations of adolescents with the disclosure and post-disclosure period.ResultsAdolescents who reported having received timely disclosure expressed that as they grew older, they began to comprehend the lifelong repercussions of an HIV diagnosis and experienced a re-emergence of the negative feelings similar to those experienced during the post-disclosure period. Those who received the knowledge of their HIV status during late adolescence experienced prolonged periods of negative self-perception and anger at not receiving their HIV status earlier. They also expressed a need for more information during the disclosure process on the prevention of onward transmission of the virus, safe conception practices resulting in HIV negative children, and information on how to disclose their HIV status to sexual partners or peers. Anticipated stigma was experienced universally by these older adolescents and was a major barrier towards adherence and coping with an HIV status. Caregivers or siblings with a similar HIV status were a source of social support. Adolescents felt that the support of peers (ALWHIV) helped them to accept their HIV status and to learn how to develop a positive outlook on life.ConclusionProvision of psychosocial care in late adolescence during the transition to adult care is critical in ensuring the resolution of re-emergent negative emotions. Comprehensive information on HIV prevention and sexual reproductive health should be a crucial component of post-disclosure care for older adolescents. HIV Disclosure and adolescent transition guidelines should include these components to optimize psychosocial care for older adolescents.

Author(s): Onono, Maricianah A; Rutherford, George W; Bukusi, Elizabeth A; White, Justin S; Goosby, Eric; Brindis, Claire D | Abstract: BackgroundApproximately one in every five adolescent girls in Kenya has either had a live birth or is pregnant with her first child. There is an urgent need to understand the language and symbols used to represent adolescent pregnancy, if the current trend in adolescent pregnancy is to be reversed. Agreement on the definition of a societal problem is an important precursor to a social issue's political prioritization and priority setting.MethodsWe apply the Public Arenas Model to appraise the environments, definitions, competition dynamics, principles of selection and current actors involved in problem-solving and prioritizing adolescent pregnancy as a policy issue. Using a focused ethnographic approach, we undertook semi-structured interviews with 14 members of adolescent sexual reproductive health networks at the national level and conducted thematic analysis of the interviews.FindingsWe found that existing definitions center around adolescent pregnancy as a "disease" that needs prevention and treatment, socially deviant behaviour that requires individual agency, and a national social concern that drains public resources and therefore needs to be regulated. These competing definitions contribute to the rarity of the topic achieving traction within the political agenda and contribute to conflicting solutions, such as lowering the legal age of consenting to sex, while limiting access to contraceptive information and services to minors.ConclusionThis paper provides a timely theoretical approach to draw attention to the different competing definitions and subsequent divergent interpretations of the problem of adolescent pregnancy in Kenya. Adolescent reproductive health stakeholders need to be familiar with the existing definitions and deliberately reframe this important social problem for better political prioritization and resource allocation. We recommend a definition of adolescent pregnancy that cuts across different arenas, and leverages already existing dominant and concurrent social and economic issues that are already on the agenda table.

Background HIV-infected youth in sub-Saharan Africa are less likely to initiate antiretroviral therapy (ART) than older adults. Setting and methods Adult (≥15 years) residents enumerated during a census in 32 communities in rural Kenya and Uganda named social contacts in 5 domains: health, money, emotional support, food, and free time. Named contacts were matched to other enumerated residents to build social networks among 150,395 adults; 90% were tested for HIV at baseline. Among youth (15-24 years) who were ART naive at baseline (2013-2014), we evaluated whether having ≥1 network contact who was HIV infected predicted ART initiation within 3 years and modification of this association by age and strength of contact, using logistic regression with robust standard errors. Results Among 1120 HIV-infected youth who were ART naive at baseline, 805 remained alive and community residents after 3 years. Of these, 270 (33.5%) named at least one baseline HIV-infected contact; 70% (569/805) subsequently initiated ART. Youth with ≥1 HIV-infected same-age baseline contact were more likely to initiate ART [adjusted odds ratio (aOR), 2.95; 95% confidence interval (CI): 1.49 to 5.86] than those with no HIV-infected contact, particularly if the contact was a strong tie (named in >1 domain; aOR, 5.33; 95% CI: 3.34 to 8.52). When nonhousehold contacts were excluded, having an HIV-infected same age contact who was a strong tie remained associated with ART initiation (aOR, 2.81; 95% CI: 1.76 to 4.49). Conclusions Interventions that increase and strengthen existing social connections to other HIV-infected peers at the time of HIV diagnosis may increase ART initiation among HIV-infected youth.