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Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n = 1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among these couples. In the month following PrEP initiation, the mean number of monthly sex acts within couples decreased from 7.9 to 6.9 (mean difference: − 1.1; 95% CI − 1.5, − 0.7) and the proportion of couples having condomless sex decreased from 65% to 32% (percentage point change: − 33%; 95% CI − 37%, − 30%); these behaviors then remained relatively constant over 2 years. We found no evidence of sexual risk compensation following PrEP initiation within African serodiscordant couples. However, roughly a third of couples continued to engage in condomless sex during follow up, emphasizing the importance of continued PrEP use to sustain HIV protection.

Background Timely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention. Methods and findings In a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23–30), median gestational age was 30 weeks (IQR 28–34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97–1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97–1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention. Conclusions In this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates. Trial registration ClinicalTrials.gov Trial Number NCT02350140., In a study in Kenya, Thomas Odeny and co-workers investigate the value of text reminders for infant HIV testing and retaining mothers in care., Author summary Why was this study done? Low retention of mother–infant pairs in postpartum HIV care poses a major threat to successful elimination of mother-to-child HIV transmission in sub-Saharan Africa. The increase in the number of mobile phone connections in sub-Saharan Africa has been spectacular, presenting a unique opportunity to add mobile technology for health (mHealth) to the armamentarium for turning the tide of HIV. We developed the Texting Improves Testing (TextIT) intervention to improve uptake of infant HIV testing and maternal retention in postpartum HIV care in a high–HIV-burden setting. Text messages were designed using behavioral theory. Women received up to 14 text messages during pregnancy and after delivery. Messages were tailored based on recipient’s gestational age, name, preferred time, desired language (English, Kiswahili, or Dholuo), date of delivery, and infant’s name. Participants had the option to respond to text messages, call, or send inquiry text messages. In a randomized controlled efficacy trial, we found that the TextIT intervention significantly improved rates of infant HIV testing and maternal retention in postpartum HIV care. To achieve policy change leading to broader implementation of this evidence-based intervention, we sought to provide evidence of effectiveness under real-world routine care conditions. What did the researchers do and find? Using an implementation science approach, we designed a cluster randomized, stepped-wedge trial with 2 time periods of observation. We randomly allocated 10 health facilities to begin implementing the intervention immediately, while the remaining 10 began implementing approximately 6 months later. Consistent with real-world implementation conditions, inclusion criteria were minimal. Women were offered the opportunity to receive text messages if they were ≥18 years old or emancipated minors and between 28 weeks’ gestation and delivery. We found that 1,466 of 1,613 (90.9%) infants in the intervention group underwent HIV testing within 8 weeks after birth compared to 609 of 713 (85.4%) in the control group. We also found that 1,548 of 1,725 (90%) women in the intervention group were retained in care during the first 8 weeks after delivery compared to 571 of 747 (76%) in the control group. What do these findings mean? We observed nonsignificant increases in infant HIV testing and maternal retention in postpartum care associated with short message service (SMS) text messaging. Nevertheless, HIV testing of >90% aligns with the global target of diagnosing >90% of all children living with HIV. Recognizing that strict adherence to statistical thresholds in implementation research may not provide optimal guidance for public health practice, interpretation of estimates of improvement in such studies should be contextualized in terms of the costs and benefits of implementing at scale.

Author(s): Olilo, Winter A; Petersen, Maya L; Koss, Catherine A; Wafula, Eric; Kwarisiima, Dalsone; Kadede, Kevin; Clark, Tamara D; Cohen, Craig R; Bukusi, Elizabeth A; Kamya, Moses R; Charlebois, Edwin D; Havlir, Diane V; Ayieko, James; SEARCH Collaboration

HIV is the leading cause of mortality for youth in sub-Saharan Africa. Youth are more likely than any other age group to be lost to follow-up (LTFU) from care. We investigated the health care-related experiences of youth living with HIV (YLWH) who were LTFU (i.e., had not returned to care for at least 4 months), as well as the perceptions of the community health workers who supported them. Data were collected from two focus group discussions with community health workers (n = 18) who worked with YLWH and 27 semistructured interviews with YLWH (ages 15-21 years) who were LTFU. Attitudes toward health care were presented in the context of a social-ecological model. Respondents highlighted the need for improved youth-oriented services, including youth-friendly clinics and training for care providers about specific needs of YLWH. Researchers should develop and test the impact of these interventions to improve retention of YLWH in care.

Summary Background Optimal strategies for pre-exposure prophylaxis (PrEP) engagement in generalised HIV epidemics are unknown. We aimed to assess PrEP uptake and engagement after population-level HIV testing and universal PrEP access to characterise gaps in the PrEP cascade in rural Kenya and Uganda. Methods We did a 72-week interim analysis of observational data from the ongoing SEARCH (Sustainable East Africa Research in Community Health) study. Following community sensitisation and PrEP education, we did HIV testing and offered PrEP at health fairs and facilities in 16 rural communities in western Kenya, eastern Uganda, and western Uganda. We provided enhanced PrEP counselling to individuals 15 years and older who were assessed as having an elevated HIV risk on the basis of serodifferent partnership or empirical risk score, or who otherwise self-identified as being at high risk but were not in serodifferent partnerships or identified by the risk score. PrEP follow-up visits were done at facilities, homes, or community locations. We assessed PrEP uptake within 90 days of HIV testing, programme engagement (follow-up visit attendance at week 4, week 12, and every 12 weeks thereafter), refills, self-reported adherence up to 72 weeks, and concentrations of tenofovir in hair samples from individuals reporting HIV risk and adherence during follow-up, and analysed factors associated with uptake and adherence. This study is registered with ClinicalTrials.gov , NCT01864603 . Findings Between June 6, 2016, and June 23, 2017, 70 379 community residents 15 years or older who had not previously been diagnosed with HIV were tested during population-level HIV testing. Of these individuals, 69 121 tested HIV-negative, 12 935 of whom had elevated HIV risk (1353 [10%] serodifferent partnership, 6938 [54%] risk score, 4644 [36%] otherwise self-identified risk). 3489 (27%) initiated PrEP, 2865 (82%) of whom did so on the same day as HIV testing and 1733 (50%) of whom were men. PrEP uptake was lower among individuals aged 15–24 years (adjusted odds ratio 0·55, 95% CI 0·45–0·68) and mobile individuals (0·61, 0·41–0·91). At week 4, among 3466 individuals who initiated PrEP and did not withdraw or die before the first visit, 2215 (64%) were engaged in the programme, 1701 (49%) received medication refills, and 1388 (40%) self-reported adherence. At week 72, 1832 (56%) of 3274 were engaged, 1070 (33%) received a refill, and 900 (27%) self-reported adherence. Among participants reporting HIV risk at weeks 4–72, refills (89–93%) and self-reported adherence (70–76%) were high. Among sampled participants self-reporting adherence at week 24, the proportion with tenofovir concentrations in the hair reflecting at least four doses taken per week was 66%, and reflecting seven doses per week was 44%. Participants who stopped PrEP accepted HIV testing at 4274 (83%) of 5140 subsequent visits; half of these participants later restarted PrEP. 29 participants of 3489 who initiated PrEP had serious adverse events, including seven deaths. Five adverse events (all grade 3) were assessed as being possibly related to the study drug. Interpretation During population-level HIV testing, inclusive risk assessment (combining serodifferent partnership, an empirical risk score, and self-identification of HIV risk) was feasible and identified individuals who could benefit from PrEP. The biggest gap in the PrEP cascade was PrEP uptake, particularly for young and mobile individuals. Participants who initiated PrEP and had perceived HIV risk during follow-up reported taking PrEP, but one-third had drug concentrations consistent with poor adherence, highlighting the need for novel approaches and long-acting formulations as PrEP roll-out expands. Funding National Institutes of Health, President's Emergency Plan for AIDS Relief, Bill & Melinda Gates Foundation, and Gilead Sciences

Objective To evaluate access to treatment after community-based HPV testing as testing within screen-and-treat programs has the potential to lower mortality from cervical cancer in low-resource settings. Methods A prospective cohort study was conducted in western Kenya in 2018. Women aged 25-65 years underwent HPV self-testing. HPV-positive women were referred for cryotherapy. Participant data were obtained from questionnaires during screening and treatment. The proportion successfully accessing treatment and variables associated with successful treatment was determined. Results Of the 750 women included, 140 (18.6%) tested positive for HPV. Of them, 135 were notified of their results, of whom 77 (59.2%) sought treatment and 73 (52.1%) received cryotherapy. Women who received treatment had a shorter time from screening to result notification (median 92 days, interquartile range [IQR] 84-104) compared to those who did not (97 days, IQR 89-106; P=0.061). In adjusted analyses, women with a history of cervical cancer screening (odds ratio [OR] 11, 95% confidence interval [CI] 1.42-85.20) and those electing result notification through a home visit (OR 4, 95% CI 1.23-14.17) were significantly more likely to acquire treatment at follow-up. Conclusion Linkage to treatment after community-based HPV screening in this population was low, highlighting the need for strategies aimed at strengthening treatment linkage in similar settings.

BACKGROUND: Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health. METHODS: We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only). RESULTS: A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39). CONCLUSIONS: Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).

New HIV infections among adolescents continues to be a large public health burden in sub-Saharan Africa, with few adolescents accessing HIV testing and counseling (HTC) services. We evaluated the effect of a peer referral program among adolescents in Kisumu county, Kenya in accessing HTC. Female adolescents aged 15 to 19years were recruited from three health clinics in Kisumu County. They, in turn, recruited their peers for HTC by handing out referral cards. Referrals would then recruit their peers and this peer-referral repeated for approximately 5months. The 252 female index seeds showed a relatively higher-risk profile for HIV compared to the 792 referral participants. The referral system yielded an increased proportion of first-time adolescent testers from 13.1% among index seeds to 42.7% among the second wave of referrals. However, the peer referral system ultimately did not increase the absolute number of adolescents Queryaccessing HTC. Future strategies should consider these findings to better target those with undiagnosed HIV infection.

Background Pre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) reduces the risk of HIV seroconversion but may promote bone mineral density (BMD) decline. The mechanisms of BMD decline with FTC/TDF remain unclear, and studies in HIV-positive individuals have been confounded by the effects of HIV and concomitant antiretroviral medications. We evaluated the impact of FTC/TDF on biomarkers of bone remodeling and bone mineral metabolism in HIV-negative men and women enrolled in the Partners PrEP Study. Methods In a random sample of HIV-negative participants randomized to FTC/TDF PrEP (n = 50) or placebo (n = 50), serum parathyroid hormone (PTH), bone biomarkers (C-telopeptide, procollagen 1 intact N-terminal propeptide, and sclerostin), and plasma fibroblast growth factor 23 were measured at baseline and month 24, and the percentage change was compared between groups. In a complementary analysis, we compared the change in biomarkers between participants with and without a 25% decline in glomerular filtration rate (GFR) on FTC/TDF. Results Baseline characteristics were similar between the groups (median age, 38 years; 40% women). Vitamin D insufficiency was common, but baseline GFR and PTH were in the normal range. We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo (P = .03), suggesting an increase in bone remodeling. We observed no differences in the other biomarkers, or in a separate analysis comparing participants with and without a decline in GFR. Conclusions Increased bone remodeling may mediate the BMD decline observed with tenofovir-containing PrEP and antiretroviral therapy, independent of a TDF-mediated decrease in kidney function.

INTRODUCTION Partner notification services (PNS) increase the HIV status knowledge and linkage to care and treatment. However, it is unclear if PNS can facilitate linkage of HIV-negative partners to prevention services such as pre-exposure prophylaxis (PrEP). Using qualitative methods, we explored provider perspective regarding the interaction of PrEP availability, PNS and antiretroviral treatment (ART) outcomes within a project integrating PrEP services into HIV care clinics in eight counties in western and central Kenya. METHODS From May 2017 to August 2018, data on integrated PrEP service delivery including its interaction with PNS were collected through 71 key informant in-depth interviews with healthcare providers and 24 standardized technical assistance reports summarizing implementation at the participating clinics. Thus, the perspective was from that of providers; analyses focused on emergent themes relating PNS to PrEP and ART services. RESULTS Providers found that PrEP integration provided an additional concrete prevention option for HIV-negative partners and created a motivation to offer PNS to persons living with HIV. PrEP availability also seemed to operate as an incentive for those living with HIV to participate in PNS, which in turn enhanced identification of potential PrEP clients and created an environment for discussing HIV transmission risk. Providers commented that initiating HIV-negative partners on PrEP enhanced mutual monitoring of health outcomes, including improved adherence to ART by partners living with HIV. Clinics noted prioritizing people living with HIV with detectable viral loads for PNS in order to identify HIV-negative partners who would benefit most from PrEP. Providers felt motivated by the apparent synergistic interaction of PNS, PrEP and ART. CONCLUSIONS Providers felt that the integration of PrEP into HIV care clinics stimulated the provision of PNS, and PNS was used to improve the identification of potential PrEP clients. The integrated combination of PNS, PrEP and ART is synergistic and should be promoted in HIV clinics.

Introduction Adolescent girls and young women (AGYW) in Africa have high HIV incidence despite scale‐up of HIV testing and HIV treatment. Placebo‐controlled trials of tenofovir‐based pre‐exposure prophylaxi (PrEP) in diverse populations demonstrated that PrEP works with close to 100% effectiveness if taken with high, but not perfect, adherence. Divergent efficacy estimates among African AGYW led to demonstration and implementation projects to better understand motivations for HIV prevention, uptake, adherence and persistence to PrEP. To inform PrEP programmes, the design and initial findings from PrEP demonstration projects for AGYW are reviewed. Discussion Early lessons from PrEP implementation projects among young African women include: (1) awareness and demand creation with positive messaging about the benefits of PrEP are critical to motivate AGYW to consider this novel prevention technology and to foster awareness among peers, partners, parents and guardians to support AGYW's effective PrEP use; (2) PrEP initiation is high in projects that are integrating PrEP into youth‐friendly clinics, family planning clinics and mobile clinics; (3) young African women at risk are initiating PrEP, based on behavioural characteristics, history of intimate partner violence, depression and 30% prevalence of chlamydia and/or gonorrhoea; (4) provision of youth‐friendly PrEP delivery programmes that integrate reproductive health services, including contraception and the diagnosis and treatment of sexually transmitted infections, increase health impact; (5) messages that emphasize the necessity for high adherence while at potential risk of HIV exposure and support strategies that addresses AGYW's adherence challenges are essential; and, (6) a substantial proportion of AGYW do not persist with PrEP, and strategies are needed to help AGYW assess their ongoing need, motivation and challenges with persisting with PrEP. Conclusions PrEP is feasible to implement in integrated reproductive health service delivery models to reach African AGYW. While PrEP demonstration projects indicate that women with behavioural risks and high rates of sexually transmitted diseases are initiating PrEP; effective strategies to support AGYW's adherence and persistence with PrEP are needed. Lessons learned from oral PrEP delivery, a novel first generation HIV prevention product, are relevant to longer‐acting and less adherence‐dependent strategies which are currently in clinical trials.

Background Human papillomavirus (HPV) is strongly associated with ano-genital and cervical cancer. Persistence of oncogenic HPV genotypes is required for development and progression of HPV-associated malignancies. Although, >70% of women clear incident HPV infections, data on natural history and HPV immunology among men is limited. Methods To evaluate cell-mediated immune response against natural HPV infection among men, we assessed cytokine (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10 and IL-13) responses in peripheral-blood-mononuclear cells (PBMCs) collected from 135 men enrolled in a prospective HPV cohort study. PBMCs were stimulated by HPV L1 gene viral-like-particles (VLP) and cytokine responses measured using a multiplex Luminex assay. Results Of 135 men included in this analysis, 41 men had persistent HPV infection, 44 men cleared HPV infection and 50 were HPV uninfected. Their mean (SD) ages were 28.9 (6.79), 27.6 (6.49) and 26.4 (4.81) years respectively. Immune response was induced in 22% (95% CI: 12.8–35.2) of HPV uninfected men, 64% (95% CI: 48.9–76.2) of men with HPV clearance and 51% (95% CI: 36.5–65.8) of men with HPV persistence. Men with HPV clearance and HPV persistence were significantly (p Conclusion In this study, Th1 cell-mediated cytokine immune response was associated with HPV clearance in men. Disclosure No significant relationships.

Background Young women account for more than half of new HIV infections in sub-Saharan Africa and are a target population for HIV pre-exposure prophylaxis (PrEP). Although it protects against HIV acquisition, PrEP lacks protection against bacterial sexually transmitted infections (STIs). High rates of STIs have been reported among PrEP-using men who have sex with men (MSM) in high income countries. STI rates among African adolescent girls and young women (AGYW) have not been well-described. Methods POWER is a multi-site PrEP implementation science project among AGYW aged 16–25 in Kisumu, Kenya (beginning August 2017) as well as South Africa; we describe results from the Kenyan cohort here. At enrollment, participants are offered PrEP; follow-up visits are at month-one and then quarterly for 36 months with STI testing at enrollment before PrEP initiation and every 6 months. Urine samples were tested for Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification (NAAT) and participants with infections returned to the research site for treatment. Results To date, 708 Kenyan women have enrolled in POWER with 17% prevalence of C. trachomatis and 8% of N. gonorrhoeae at enrollment. Among the 65 women with 6-month follow-up in Kenya; the incidence of C. trachomatis and N. gonorrhoeae were 40.0 and 12.3 per 100 person-years. Conclusion In a PrEP scale-up cohort among Kenyan AGYW, STI prevalence and incidence were very high, which predict substantial morbidity. These STI rates are comparable to those seen among PrEP-using MSM in the US after years of rising rates; Kenya has had only early PrEP roll-out and thus these findings are largely prior to community delivery of PrEP. It is not yet known if STI rates will increase among with PrEP use in Kenya, and PrEP roll-out programs provide a crucial opportunity to address both HIV and STI epidemics simultaneously. Disclosure No significant relationships.

While food insecurity and poverty worsen mental health outcomes among people living with HIV/AIDS (PLHIV), few intervention studies have targeted poverty and food insecurity as a way to improve mental health. Among HIV-positive patients, addressing such upstream determinants may prove crucial to ensure better mental health and HIV clinical outcomes. We integrated longitudinal, qualitative research into a randomized trial of a livelihood intervention to understand processes and mechanisms for how the intervention may affect mental health among HIV-infected Kenyan adults. In-depth interviews were conducted with intervention participants ( n = 45) and control participants ( n = 9) at two time-points (after intervention start and upon intervention end). Interviews ( n = 85) were translated, double-coded, and analyzed thematically using an inductive-deductive team approach. Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future. Improvements in mental health appear to occur via several mechanisms including: 1) better food security and income; 2) increased physical activity and ability to create fruitful routines around farm work; and, 3) improved sense of self as an active member of the community. Qualitative, longitudinal interviews may help identify intervention mechanisms for improved mental health, but additional research is required to confirm self-reports of mental health changes. These findings suggest that livelihood interventions may improve mental health in multi-faceted ways, and help PLHIV better integrate with their communities. Trial registered at ClinicalTrials.gov: NCT01548599

Men desire to be involved in their partner's decision-making about vaginal microbicide use. This coincides with women's desire to inform male partners about their microbicide use. Educating men about microbicides may enhance acceptability and generate critical support for the female participants of microbicide trials. In this multiphase mixed-methods study, we adapted an educational intervention on vaginal microbicides and tested it among men (n = 45) to determine its effect on men's knowledge regarding HIV/STI, vaginal microbicides and microbicide trials. We also conducted focus group discussions (FGDs) with the female partners (K = 3, n = 43) of the study participants and community representatives (K = 2, n = 24) to obtain their views on male partner microbicide education. We analysed FGD data for key themes using content analysis. HIV and vaginal microbicide knowledge scores increased significantly among men after the educational intervention. Both women and men highly supported male partner microbicide education, in the context of existing gender relations, to increase men's understanding about microbicides, promote adherence and help women gain their partners' trust. Complex gender dynamics should be considered when designing male partner educational interventions to improve acceptability and the use of microbicides and other female-initiated HIV prevention methods.

Background Despite cervical cancer being preventable with effective screening programs, it is the most common cancer and the leading cause of cancer-related death among women in many countries in Africa. Screening involving pelvic examination may not be feasible or acceptable in limited-resource settings. We sought to evaluate women’s perspectives on human papillomavirus (HPV) self-sampling as part of a larger trial on cervical cancer prevention implementation strategies in rural western Kenya. Methods We invited 120 women participating in a cluster randomized trial of cervical cancer screening implementation strategies in Migori County, Kenya for in-depth interviews. We explored reasons for testing, experience with and ability to complete HPV self-sampling, importance of clinician involvement during screening, factors and people contributing to screening decision-making, and ways to encourage other women to come for screening. We used validated theoretical frameworks to analyze the qualitative data. Results Women reported having positive experiences with the HPV self-sampling strategy. The factors facilitating uptake included knowledge and beliefs such as prior awareness of HPV, personal perception of cervical cancer risk, desire for improved health outcomes, and peer and partner encouragement. Logistical and screening facilitators included confidence in the ability to complete HPV self-sampling strategy, proximity to screening sites and feelings of privacy and comfort conducting the HPV self- sampling. The barriers to screening included fear of need for a pelvic exam, fear of disease and death associated with cervical cancer. We classified these findings as capabilities, opportunities and motivations for health behavior using the COM-B framework. Conclusions Overall, HPV self-sampling was an acceptable cervical cancer screening strategy that seemed to meet the needs of the women in this community. These findings will further inform aspects of implementation, including outreach messaging, health education, screening sites and emphasis on availability and effectiveness of preventative treatment for women who screen positive.

Mobility in sub-Saharan Africa links geographically-separate HIV epidemics, intensifies transmission by enabling higher-risk sexual behavior, and disrupts care. This population-based observational cohort study measured complex dimensions of mobility in rural Uganda and Kenya. Survey data were collected every 6 months beginning in 2016 from a random sample of 2308 adults in 12 communities across three regions, stratified by intervention arm, baseline residential stability and HIV status. Analyses were survey-weighted and stratified by sex, region, and HIV status. In this study, there were large differences in the forms and magnitude of mobility across regions, between men and women, and by HIV status. We found that adult migration varied widely by region, higher proportions of men than women migrated within the past one and five years, and men predominated across all but the most localized scales of migration: a higher proportion of women than men migrated within county of origin. Labor-related mobility was more common among men than women, while women were more likely to travel for non-labor reasons. Labor-related mobility was associated with HIV positive status for both men and women, adjusting for age and region, but the association was especially pronounced in women. The forms, drivers, and correlates of mobility in eastern Africa are complex and highly gendered. An in-depth understanding of mobility may help improve implementation and address gaps in the HIV prevention and care continua.

Supplemental Digital Content is Available in the Text., Introduction: As countries move toward universal HIV treatment, many individuals fail to link to care after diagnosis of HIV. Efficient and effective linkage strategies are needed. Methods: We implemented a patient-centered, multicomponent linkage strategy in the SEARCH “test-and-treat” trial (NCT 01864603) in Kenya and Uganda. After population-based, community-wide HIV testing, eligible participants were (1) introduced to clinic staff after testing, (2) provided a telephone “hot-line” for enquiries, (3) provided an appointment reminder phone call, (4) given transport reimbursement on linkage, and (5) tracked if linkage appointment was missed. We estimated the proportion linked to care within 1 year and evaluated factors associated with linkage at 7, 30, and 365 days after diagnosis. Results: Among 71,308 adults tested, 6811 (9.6%) were HIV-infected; of these, 4760 (69.9%) were already in HIV care, and 30.1% were not. Among 2051 not in care, 58% were female, median age was 32 (interquartile range 26–40) years, and median CD4 count was 493 (interquartile range 331–683) cells/µL. Half (49.7%) linked within 1 week, and 73.4% linked within 1 year. Individuals who were younger [15–34 vs. >35 years, adjusted Risk Ratio (aRR) 0.83, 95% confidence interval (CI): 0.74 to 0.94], tested at home vs. community campaign (aRR = 0.87, 95% CI: 0.81 to 0.94), had a high HIV-risk vs. low-risk occupation (aRR = 0.81, 95% CI: 0.75 to 0.88), and were wealthier (aRR 0.90, 95% CI: 0.83 to 0.97) were less likely to link. Linkage did not differ by marital status, stable residence, level of education, or having a phone contact. Conclusions: Using a multicomponent linkage strategy, high proportions of people living with HIV but not in care linked rapidly after HIV testing.

To catalyze national scale up of PrEP for HIV serodiscordant couples in public health facilities in Kenya, the Partners Scale-Up Project, using a two-day case-based interactive curriculum, trained health care providers working in 24 high volume facilities in central and western Kenya on PrEP service delivery. Using a standardized test with questions about PrEP and antiretroviral-based HIV prevention we assessed gain in knowledge and confidence gain by comparing pre-and post-training test scores. We explored experiences of the training through key informant interviews after clinics started delivering PrEP. Of 716 health care providers trained, 235 (32.9%) were nurses, 144 (20.2%) were clinical officers and 155 (21.7%) were HIV counsellors. There was a significant improvement between the means of pre-test and post-test scores (61.7% (SD 17.4) vs 86.4% (SD 12.7) p

For people living with HIV, exposure to sexual violence (SV) is associated with decreased adherence to antiretroviral medication, a primary predictor of their survival. Identification of risk factors for SV is a pressing issue in sub-Saharan Africa, where the global majority of HIV-positive women live and the prevalence of SV against women is high. We used qualitative data to examine SV against HIV-positive women enrolled in HIV care in Kenya. Respondents identified husbands as perpetrators of SV in the context of women's efforts to use condoms as directed by HIV care providers.

Background: In 2013-2014 we achieved 89% adult HIV testing coverage using a hybrid testing approach in 32 communities in Uganda and Kenya (SEARCH: NCT01864603). To inform scalability we sought to determine: (1) overall cost and efficiency of this approach; and (2) costs associated with point-of-care (POC) CD4 testing multidisease services and community mobilization. Methods: We applied microcosting methods to estimate costs of population-wide HIV testing in 12 SEARCH trial communities. Main intervention components of the hybrid approach are census multidisease community health campaigns (CHC) and homebased testing for CHC nonattendees. POC CD4 tests were provided for all HIV-infected participants. Data were extracted from expenditure records activity registers staff interviews and time and motion logs. Results: The mean cost per adult tested for HIV was $20.5 (range: $17.1-$32.1) (2014 US$) including a POC CD4 test at $16 per HIV+ person identified. Cost per adult tested for HIV was $13.8 at CHC vs. $31.7 by home-based testing. The cost per HIV+ adult identified was $231 ($87-$1245) with variability due mainly to HIV prevalence among persons tested (ie HIV positivity rate). The marginal costs of multidisease testing at CHCs were $1.16/person for hypertension and diabetes and $0.90 for malaria. Community mobilization constituted 15.3% of total costs. Conclusions: The hybrid testing approach achieved very high HIV testing coverage with POC CD4 at costs similar to previously reported mobile home-based or venue-based HIV testing approaches in sub-Saharan Africa. By leveraging HIV infrastructure multidisease services were offered at low marginal costs. Copyright © 2016 Wolters Kluwer Health Inc. All rights reserved.

The effective functioning of a research ethics committee (REC) can be evaluated using self-assessment tools. The Middle East Research Ethics Training Initiative (MERETI) tool can be used by one member, typically the Chair, to score an REC. The consistency of these scores across several members of an REC has never been evaluated. This study examined whether results would be consistent irrespective of who conducts the assessment. One REC’s effective functioning was assessed by several members ( n = 13). The Chair’s scores were compared with scores of other members in relation to their duration of REC membership, research ethics training, gender, and employer’s institutional affiliation to the REC. The Chair’s overall score was higher than the other members’ scores by 11%. No significant differences in scores were obtained in relation to duration of REC membership ( p = .72), interval since last research ethics training ( p = .94), and gender ( p = .27). The MERETI tool is thus consistent irrespective of who performs the assessment.

Objective We sought to increase adolescent HIV testing across rural communities in east Africa and identify predictors of undiagnosed HIV. Design Hybrid mobile testing. Methods We enumerated 116 326 adolescents (10-24 years) in 32 communities of Uganda and Kenya ( Search NCT01864603): 98 694 (85%) reported stable (≥6 months of prior year) residence. In each community we performed hybrid testing: 2-week multidisease community health campaign that included HIV testing, followed by home-based testing of community health campaign nonparticipants. We measured adolescent HIV testing coverage and prevalence, and determined predictors of newly diagnosed HIV among HIV-infected adolescents using multivariable logistic regression. Results A total of 86 421 (88%) stable adolescents tested for HIV; coverage was 86, 90, and 88% in early (10-14), mid (15-17), and late (18-24) adolescents, respectively. Self-reported prior testing was 9, 26, and 55% in early, mid, and late adolescents tested, respectively. HIV prevalence among adolescents tested was 1.6 and 0.6% in Ugandan women and men, and 7.1 and 1.5% in Kenyan women and men, respectively. Prevalence increased in mid-adolescence for women and late adolescence for men. Among HIV-infected adolescents, 58% reported newly diagnosed HIV. In multivariate analysis of HIV-infected adolescents, predictors of newly diagnosed HIV included male sex [odds ratio (OR) = 1.97 (95% confidence interval (CI): 1.42-2.73)], Ugandan residence [OR = 2.63 (95% CI: 2.08-3.31)], and single status [OR = 1.62 (95% CI: 1.23-2.14) vs. married)]. Conclusions The SEARCH hybrid strategy tested 88% of stable adolescents for HIV, a substantial increase over the 28% reporting prior testing. The majority (57%) of HIV-infected adolescents were new diagnoses. Mobile HIV testing for adults should be leveraged to reach adolescents for HIV treatment and prevention.

Combination antiretroviral therapy (ART) decreases the risk of sexual HIV transmission by suppressing blood and genital HIV RNA concentrations. We sought to determine HIV transmission risk prior to achieving complete viral suppression.Prospective cohort study.Using data from the Partners PrEP Study, a prospective study of 4747 heterosexual HIV-serodiscordant couples in Kenya and Uganda, we examined multiple markers of HIV transmission risk during the first months after ART initiation: time to viral suppression in blood, persistence of HIV RNA in genital specimens, sexual risk behavior, pregnancy incidence, and HIV transmission using survival analysis and generalized estimating equations logistic regression.The cumulative probabilities of achieving blood viral suppression (80 copies per milliliter) 3, 6, and 9 months after ART initiation were 65.3%, 84.8%, and 89.1%, respectively. Endocervical and seminal HIV RNA were detectable in 12% and 21% of samples obtained within 6 months of ART. Pregnancy incidence was 8.8 per 100 person-years during the first 6 months of ART, and sex unprotected by condoms was reported at 10.5% of visits. Among initially uninfected partners, HIV incidence before ART was 2.08 per 100 person-years (55 infections; 2644 person-years), 1.79 for 0-6 months after ART initiation (3 infections; 168 person-years), and 0.00 with6 months of ART (0 infections; 167 person-years).Residual HIV transmission risk persists during the first 6 months of ART, with incomplete viral suppression in blood and genital compartments. For HIV-serodiscordant couples in which the infected partner starts ART, other prevention options are needed, such as pre-exposure prophylaxis, until viral suppression is achieved.

© 2016 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. ABSTRACT: Men’s uptake of HIV testing is critical to the success of “test and treat” strategies in generalized epidemics. This study sought to identify cultural factors and community processes that influence men’s HIV testing uptake in the baseline year of an ongoing test-and-treat trial among 334,479 persons in eastern Africa (SEARCH, NCT#01864603). Data were collected using participant observation at mobile community health campaigns (CHCs) (n = 28); focus group discussions (n = 8 groups) with CHC participants; and in-depth interviews with care providers (n = 50), leaders (n = 32), and members (n = 112) of eight communities in Kenya and Uganda. An 8-person research team defined analytical codes and iteratively refined them during data collection using grounded theoretical approaches, and textual data were coded using Atlas.ti software. Structural and cultural barriers, including men’s mobility and gender norms valorizing risk-taking and discouraging health-seeking behavior, were observed, and contributed to men’s lower participation in HIV testing relative to women. Men’s labor opportunities often require extended absences from households: during planting season, men guarded fields from monkeys from dawn until nightfall; lake fishermen traveled long distances and circulated between beaches. Men often tested “by proxy”, believing their wives’ HIV test results to be their status. Debates about HIV risks were vigorous, with many men questioning “traditional” masculine gender norms that enhanced risks. The promise of antiretroviral therapy (ART) to prolong health was a motivating factor for many men to participate in testing. Flexibility in operating hours of HIV testing including late evening and weekend times along with multiple convenient locations that moved were cited as facilitating factors enhancing male participating in HIV testing. Mobile testing reduced but did not eliminate barriers to men’s participation in a large-scale “test & treat” effort. However, transformations in gender norms related to HIV testing and care-seeking are underway in eastern Africa and should be supported.

Expectations about future health and longevity are important determinants of individuals’ decisions to invest in physical and human capital. Few population-level studies have measured subjective expectations and examined how they are affected by scale-up of antiretroviral therapy (ART). We assessed these expectations in communities receiving annual HIV testing and universal ART. Longitudinal data on expectations were collected at baseline and one year later in 16 intervention communities participating in the Sustainable East Africa Research in Community Health (SEARCH) trial of the test and treat strategy in Kenya and Uganda (NCT01864603). A random sample of households with and without an HIV-positive adult was selected after baseline HIV testing. Individuals’ expectations about survival to 50, 60, 70, and 80 years of age, as well as future health status and economic well-being, were measured using a Likert scale. Primary outcomes were binary variables indicating participants who reported being very likely or almost certain to survive to advanced ages. Logistic regression analyses were used to examine trends in expectations as well as associations with HIV status and viral load for HIV-positive individuals. Data were obtained from 3126 adults at baseline and 3977 adults in year 1, with 2926 adults participating in both waves. HIV-negative adults were more likely to have favorable expectations about survival to 60 years than HIV-positive adults with detectable viral load (adjusted odds ratio [AOR] 1.87, 95% CI 1.53–2.30), as were HIV-positive adults with undetectable viral load (AOR 1.41, 95% CI 1.13–1.77). Favorable expectations about survival to 60 years were more likely for all groups in year 1 compared to baseline (AOR 1.53, 95% CI 1.31–1.77). These findings are consistent with the hypothesis that universal ART leads to improved population-level expectations about future health and well-being. Future research from the SEARCH trial will help determine whether these changes are causally driven by the provision of universal ART.

OBJECTIVE Two distinct hypotheses have been proposed for T-cell involvement in protection from HIV-1 acquisition. First, HIV-1-specific memory T-cell responses generated on HIV-1 exposure could mount an efficient response to HIV-1 and inhibit the establishment of an infection. Second, a lower level of immune activation could reduce the numbers of activated, HIV-1-susceptible CD4 T cells, thereby diminishing the likelihood of infection. METHODS To test these hypotheses, we conducted a prospective study among high-risk heterosexual men and women, and tested peripheral blood samples from individuals who subsequently acquired HIV-1 during follow-up (cases) and from a subset of those who remained HIV-1 uninfected (controls). RESULTS We found no difference in HIV-1-specific immune responses between cases and controls, but Treg frequency was higher in controls as compared with cases and was negatively associated with frequency of effector memory CD4 T cells. CONCLUSIONS Our findings support the hypothesis that low immune activation assists in protection from HIV-1 infection.

Supplemental Digital Content is Available in the Text., Background: Scale-up of triple-drug antiretroviral therapy (ART) in Africa has transformed the context of childbearing for HIV-positive women and may impact pregnancy incidence in HIV programs. Methods: Using observational data from 47,313 HIV-positive women enrolled at 26 HIV clinics in Kenya and Uganda between 2001 and 2009, we calculated the crude cumulative incidence of pregnancy for the pre-ART and on-ART periods. The causal effect of ART use on incident pregnancy was assessed using inverse probability weighted marginal structural models, and the relationship was further explored in multivariable Cox models. Results: Crude cumulative pregnancy incidence at 1 year after enrollment/ART initiation was 4.0% and 3.9% during the pre-ART and on-ART periods, respectively. In marginal structural models, ART use was not significantly associated with incident pregnancy [hazard ratio = 1.06; 95% confidence interval (CI): 0.99 to 1.12]. Similarly, in Cox models, there was no significant relationship between ART use and incident pregnancy (cause-specific hazard ratio: 0.98; 95% CI: 0.91 to 1.05), but effect modification was observed. Specifically, women who were pregnant at enrollment and on ART had an increased risk of incident pregnancy compared to those not pregnant at enrollment and not on ART (cause-specific hazard ratio: 1.11; 95% CI: 1.01 to 1.23). Conclusions: In this large cohort, ART initiation was not associated with incident pregnancy in the general population of women enrolling in HIV care but rather only among those pregnant at enrollment. This finding further highlights the importance of scaling up access to lifelong treatment for pregnant women.

Summary Background Despite large investments in HIV testing, only an estimated 45% of HIV-infected people in sub-Saharan Africa know their HIV status. Optimum methods for maximising population-level testing remain unknown. We sought to show the effectiveness of a hybrid mobile HIV testing approach at achieving population-wide testing coverage. Methods We enumerated adult (≥15 years) residents of 32 communities in Uganda (n=20) and Kenya (n=12) using a door-to-door census. Stable residence was defined as living in the community for at least 6 months in the past year. In each community, we did 2 week multiple-disease community health campaigns (CHCs) that included HIV testing, counselling, and referral to care if HIV infected; people who did not participate in the CHCs were approached for home-based testing (HBT) for 1–2 months within the 1–6 months after the CHC. We measured population HIV testing coverage and predictors of testing via HBT rather than CHC and non-testing. Findings From April 2, 2013, to June 8, 2014, 168 772 adult residents were enumerated in the door-to-door census. HIV testing was achieved in 131 307 (89%) of 146 906 adults with stable residence. 13 043 of 136 033 (9·6%, 95% CI 9·4–9·8) adults with and without stable residence had HIV; median CD4 count was 514 cells per μL (IQR 355–703). Among 131 307 adults with stable residence tested, 56 106 (43%) reported no previous testing. Among 13 043 HIV-infected adults, 4932 (38%) were unaware of their status. Among 105 170 CHC attendees with stable residence 104 635 (99%) accepted HIV testing. Of 131 307 adults with stable residence tested, 104 635 (80%; range 60–93% across communities) tested via CHCs. In multivariable analyses of adults with stable residence, predictors of non-testing included being male (risk ratio [RR] 1·52, 95% CI 1·48–1·56), single marital status (1·70, 1·66–1·75), age 30–39 years (1·58, 1·52–1·65 vs 15–19 years), residence in Kenya (1·46, 1·41–1·50), and migration out of the community for at least 1 month in the past year (1·60, 1·53–1·68). Compared with unemployed people, testing for HIV was more common among farmers (RR 0·73, 95% CI 0·67–0·79) and students (0·73, 0·69–0·77); and compared with people with no education, testing was more common in those with primary education (0·84, 0·80–0·89). Interpretation A hybrid, mobile approach of multiple-disease CHCs followed by HBT allowed for flexibility at the community and individual level to help reach testing coverage goals. Men and mobile populations remain challenges for universal testing. Funding National Institutes of Health and President's Emergency Plan for AIDS Relief.

BACKGROUND: We sought to understand whether women’s empowerment and male partner engagement were associated with use of antenatal care (ANC). METHODS: Women presenting for ANC in Nyanza province of Kenya during June 2015-May 2016, were approached for participation. A total of 137 pregnant women and 96 male partners completed baseline assessments. Women’s empowerment was measured using the modified Sexual Relationship Power Scale. ANC use measures included timing of the first ANC visit and number of visits. Male engagement was based on whether a husband reported accompanying his wife to one or more antenatal visits during the pregnancy. Multiple linear and logistic regression analyses were used to identify factors independently related to use and timing of ANC. RESULTS: Women with higher mean empowerment scores were likely to have more than one ANC visit in the index pregnancy (Adjusted Odds Ratio (AOR)=2.8, 95% Confidence Interval (CI): 1.1–7.3), but empowerment was not associated with early ANC use. Women who were more empowered were less likely to have a husband who reported attending an ANC visit with his wife (AOR=0.1, 95% CI: 0.03–0.8). CONCLUSIONS: Women’s empowerment is important and may be related to ANC use and engagement of male partners in complex ways.

Adolescent girls and young women (AGYW) are highly affected by the HIV epidemic, yet standard approaches to pre-exposure prophylaxis (PrEP) delivery will not meet their needs. This commentary highlights key characteristics of AGYW related to PrEP use and delivery, including typical neurocognitive development, lack of experience with sustained medication use, and the social and connected nature of AGYW’s lives. We then suggest ways for programs to embrace these characteristics, such as presenting PrEP as a lifestyle choice and not a biomedical tool, making access to PrEP simple and easy, and recognizing the many influences AGYW face in taking PrEP. We also suggest ways for programs to identify AGYW at the highest risk of HIV acquisition. Adolescent girls and young women have an important role to play in ending the HIV epidemic and they deserve considerable, tailored investment.

Introduction HIV care and treatment in cross‐border areas in East Africa face challenges perhaps not seen to the same extent in other geographic areas, particularly for mobile and migrant populations. Here, we estimate the proportion of people with HIV found in these cross‐border areas in each stage of the HIV care and treatment cascade, including the proportion who knows their status, the proportion on treatment and the proportion virally suppressed. Methods Participants (n = 11,410) working or socializing in public places in selected East Africa cross border areas were recruited between June 2016 and February 2017 using the Priorities for Local AIDS Control Efforts method and administered a behavioural survey and rapid HIV test. This approach was designed to recruit a stratified random sample of people found in public spaces or venues in each cross border area. For participants testing positive for HIV, viral load was measured from dried blood spots. The proportion in each step of the cascade was estimated using inverse probability weights to account for the sampling design and informative HIV test refusals. Estimates are reported separately for residents of the cross border areas and non‐residents found in those areas. Results Overall, 43% of participants with HIV found in cross‐border areas knew their status, 87% of those participants were on antiretroviral therapy (ART), and 80% of participants on ART were virally suppressed. About 20% of people with HIV found in cross border areas were sampled outside their subdistrict or subcounty of residence. While both resident and non‐resident individuals who knew their status were likely to be on ART (85% and 96% respectively), people on ART recruited outside their area of residence were less likely to be suppressed (64% suppressed; 95% CI: 43, 81) compared to residents (84% suppressed; 95% CI: 75, 93). Conclusions People living in or travelling through cross‐border areas may face barriers in learning their HIV status. Moreover, while non‐residents were more likely to be on treatment than residents, they were less likely to be suppressed, suggesting gaps in continuity of care for people in East Africa travelling outside their area of residence despite timely initiation of treatment.

A growing body of evidence highlights the importance of competent mentoring in academic research. We describe the development, implementation, and evaluation of four regional 2-day intensive workshops to train mid- and senior-level investigators conducting public health, clinical, and basic science research across multiple academic institutions in low- and middle-income countries (LMICs) on tools and techniques of effective mentoring. Sponsored by the Fogarty International Center, workshops included didactic presentations, interactive discussions, and small-group problem-based learning and were conducted in Lima, Peru; Mombasa, Kenya; Bangalore, India; and Johannesburg, South Africa, from 2013 to 2016. Mid- or senior-level faculty from multiple academic institutions within each region applied and were selected. Thirty faculty from 12 South America–based institutions, 29 faculty from eight East Africa–based institutions, 37 faculty from 14 South Asia–based institutions, and 36 faculty from 13 Africa-based institutions participated, with diverse representation across disciplines, gender, and academic rank. Discussions and evaluations revealed important comparisons and contrasts in the practice of mentoring, and specific barriers and facilitators to mentoring within each cultural and regional context. Specific regional issues related to hierarchy, the post-colonial legacy, and diversity arose as challenges to mentoring in different parts of the world. Common barriers included a lack of a culture of mentoring, time constraints, lack of formal training, and a lack of recognition for mentoring. These workshops provided valuable training, were among the first of their kind, were well-attended, rated highly, and provided concepts and a structure for the development and strengthening of formal mentoring programs across LMIC institutions.

Author(s): Onono, Maricianah Atieno; Brindis, Claire D; White, Justin S; Goosby, Eric; Okoro, Dan Odhiambo; Bukusi, Elizabeth Anne; Rutherford, George W | Abstract: BackgroundDespite the high burden of adverse adolescent sexual and reproductive health (SRH) outcomes, it has remained a low political priority in Kenya. We examined factors that have shaped the lack of current political prioritization of adolescent SRH service provision.MethodsWe used the Shiffman and Smith policy framework consisting of four categories-actor power, ideas, political contexts, and issue characteristics-to analyse factors that have shaped political prioritization of adolescent SRH. We undertook semi-structured interviews with 14 members of adolescent SRH networks between February and April 2019 at the national level and conducted thematic analysis of the interviews.FindingsSeveral factors hinder the attainment of political priority for adolescent SRH in Kenya. On actor power, the adolescent SRH community was diverse and united in adoption of international norms and policies, but lacked policy entrepreneurs to provide strong leadership, and policy windows were often missed. Regarding ideas, community members lacked consensus on a cohesive public positioning of the problem. On issue characteristics, the perception of adolescents as lacking political power made politicians reluctant to act on the existing data on the severity of adolescent SRH. There was also a lack of consensus on the nature of interventions to be implemented. Pertaining to political contexts, sectoral funding by donors and government treasury brought about tension within the different government ministries resulting in siloed approaches, lack of coordination and overall inefficiency. However, the SRH community has several strengths that augur well for future political support. These include the diverse multi-sectoral background of its members, commitment to improving adolescent SRH, and the potential to link with other health priorities such as maternal health and HIV/AIDS.ConclusionIn order to increase political attention to adolescent SRH in Kenya, there is an urgent need for policy actors to: 1) create a more cohesive community of advocates across sectors, 2) develop a clearer public positioning of adolescent SRH, 3) agree on a set of precise approaches that will resonate with the political system, and 4) identify and nurture policy entrepreneurs to facilitate the coupling of adolescent SRH with potential solutions when windows of opportunity arise.

Author(s): Mmeje, Okeoma; Njoroge, Betty; Wekesa, Pauline; Murage, Alfred; Ondondo, Raphael O; van der Poel, Sheryl; Guze, Mary A; Shade, Starley B; Bukusi, Elizabeth A; Cohan, Deborah; Cohen, Craig R | Abstract: BackgroundFemale positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children.MethodsA prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant.FindingsForty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (≥ 400 copies/mL).ConclusionTimed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs.

Following the Fogarty International Center-supported “Mentoring the Mentors” workshops in South America, Africa, and Asia, approaches and guidelines for mentorship at institutions within these low- and middle-income country (LMIC) contexts, appropriate for the respective regional resources and culture, were implemented. Through the presentation of case studies from these three geographic regions, this article illustrates the institutional mentorship infrastructure before the workshop and the identified gaps used to implement strategies to build mentorship capacity at the Universidad Peruana Cayetano Heredia (Peru), Kenya Medical Research Institute (Kenya), Saint John’s Research Institute (India), and Eduardo Mondlane University (Mozambique). These case studies illustrate three findings: first, that mentorship programs in LMICs have made uneven progress, and institutions with existing programs have exhibited greater advancement to their mentoring capacity than institutions without formal programs before the workshops. Second, mentoring needs assessments help garner the support of institutional leadership and create local ownership. Third, developing a culture of mentorship that includes group mentoring activities at LMIC institutions can help overcome the shortage of trained mentors. Regardless of the stage of mentoring programs, LMIC institutions can work toward developing sustainable, culturally effective mentorship models that further the partnership of early career scientists and global health.

Author(s): Brown, Lillian B; Getahun, Monica; Ayieko, James; Kwarisiima, Dalsone; Owaraganise, Asiphas; Atukunda, Mucunguzi; Olilo, Winter; Clark, Tamara; Bukusi, Elizabeth A; Cohen, Craig R; Kamya, Moses R; Petersen, Maya L; Charlebois, Edwin D; Havlir, Diane V; Camlin, Carol S | Abstract: BackgroundPrevious research indicates clinical outcomes among HIV-infected men in sub-Saharan Africa are sub-optimal. The SEARCH test and treat trial (NCT01864603) intervention included antiretroviral care delivery designed to address known barriers to HIV-care among men by decreasing clinic visit frequency and providing flexible, patient-centered care with retention support. We sought to understand facilitators and barriers to retention in care in this universal treatment setting through quantitative and qualitative data analysis.MethodsWe used a convergent mixed methods study design to evaluate retention in HIV care among adults (age g = 15) during the first year of the SEARCH (NCT01864603) test and treat trial. Cox proportional hazards regression was used to evaluate predictors of retention in care. Longitudinal qualitative data from n = 190 in-depth interviews with HIV-positive individuals and health care providers were analyzed to identify facilitators and barriers to HIV care engagement.ResultsThere were 1,863 men and 3,820 women who linked to care following baseline testing. Retention in care was 89.7% (95% CI 87.0-91.8%) among men and 89.0% (86.8-90.9%) among women at one year. In both men and women older age was associated with higher rates of retention in care at one year. Additionally, among men higher CD4+ at ART initiation and decreased time between testing and ART initiation was associated with higher rates of retention. Maintaining physical health, a patient-centered treatment environment, supportive partnerships, few negative consequences to disclosure, and the ability to seek care in facilities outside of their community of residence were found to promote retention in care.ConclusionsFeatures of the ART delivery system in the SEARCH intervention and social and structural advantages emerged as facilitators to retention in HIV care among men. Messaging around the health benefits of early ART start, decreasing logistical barriers to HIV care, support of flexible treatment environments, and accelerated linkage to care, are important to men's success in ART treatment programs. Men already benefit from increased social support following disclosure of their HIV-status. Future efforts to shift gender norms towards greater equity are a potential strategy to support high levels of engagement in care for both men and women.

Background: Sub-Saharan Africa faces twin epidemics of HIV and non-communicable diseases including hypertension. While integration of hypertension care into the chronic HIV-focused healthcare infrastructure is a key global priority, cost estimates for integration are largely unavailable. In the SEARCH Study, we performed population-based testing for HIV and hypertension and offered integrated streamlined chronic care. Here, we estimate costs for hypertension care integrated with HIV care for HIV-positive individuals, and the cost for hypertension care for HIV-negative people concomitantly in the same clinics. Methods: SEARCH (NCT:01864603) conducted community health campaigns for diagnosis and linkage to care for both HIV and hypertension. HIV-positive patients received hypertension/HIV care jointly including blood pressure monitoring and medications; HIV-negative patients received hypertension care alone at the same clinics. Within 10 Ugandan study communities during 2015-2016, we estimated incremental annual per-patient costs for hypertension care using standard micro-costing techniques, time-and-motion personnel studies, and administrative/clinical records review. Findings: Overall, 70 HIV-positive and 2355 HIV-negative participants received hypertension care. For HIV-positive participants, average incremental cost of hypertension care was $6.29/person/year, representing a 2.1% marginal increased cost over previously published estimates for HIV care alone. For HIV-negative persons, hypertension care cost $11.39/person/year, a 3.8% marginal increase over HIV care costs. Key costs for HIV-positive patients included hypertension medications ($6.19/patient/year; 98% of total) and laboratory testing ($0.10/ patient/year;2%). Key costs for HIV-negative patients included medications ($5.09/patient/year;45%) and clinic staff salaries ($3.66/patient/year;32%), while minor costs included laboratory testing ($0.10/patient/year;1%), fixed costs ($1.98/patient/year;17%) and other recurring costs ($0.56/patient/year;5%). Interpretation: For only 2-4% estimated additional costs, hypertension care was added to HIV care, and also expanded to all HIV-negative patients in prototypic Ugandan clinics, demonstrating substantial synergy. Our results should encourage accelerated scale-up of hypertension care into existing clinics to address the growing hypertension epidemic, secondarily reduce HIV care-related stigma, and improve community health. Funding: Research reported in this manuscript was supported by Division of AIDS, NIAID, of the National Institutes of Health under award number U01AI099959 and in part by the President’s Emergency Plan for AIDS Relief (PEPFAR), and Gilead Sciences. Declaration of Interest: Related to work in this manuscript, all authors declare no conflicts of interests. Ethical Approval: The SEARCH Study was approved by institutional review boards at Makerere University College of Health Sciences (Kampala, Uganda), the Kenya Medical Research Institute (Nairobi, Kenya), and the University of California, San Francisco, as well as by the Uganda National Council for Science and Technology.

Mentoring is a proven path to scientific progress, but it is not a common practice in low- and middle-income countries (LMICs). Existing mentoring approaches and guidelines are geared toward high-income country settings, without considering in detail the differences in resources, culture, and structure of research systems of LMICs. To address this gap, we conducted five Mentoring-the-Mentor workshops in Africa, South America, and Asia, which aimed at strengthening the capacity for evidence-based, LMIC-specific institutional mentoring programs globally. The outcomes of the workshops and two follow-up working meetings are presented in this special edition of the American Journal of Tropical Medicine and Hygiene. Seven articles offer recommendations on how to tailor mentoring to the context and culture of LMICs, and provide guidance on how to implement mentoring programs. This introductory article provides both a prelude and executive summary to the seven articles, describing the motivation, cultural context and relevant background, and presenting key findings, conclusions, and recommendations.

Efficient ways to identify children with HIV in the context of universal test-and-treat policies are needed. We evaluated a hybrid testing strategy combining mobile community and home-based HIV testing in 87,700 children across 32 rural communities in 2 East African countries. This approach resulted in 81% testing coverage of at-risk children and doubled the number of children diagnosed with HIV.

BACKGROUND: Understanding how women use PrEP is important for developing successful implementation programs. We hypothesized there are distinct patterns of adherence, related to HIV risk and other factors. SETTING & METHODS: We identified patterns of PrEP adherence and HIV risk behavior over the first 6 months of PrEP use, using data from 233 HIV-uninfected women in high-risk serodiscordant couples in a demonstration project in Kenya & Uganda. We modeled PrEP adherence, assessed by daily electronic monitoring, and HIV risk behavior using group-based trajectory models. We tested baseline covariates and risk behavior group as predictors of adherence patterns. RESULTS: There were four distinct adherence patterns: high steady adherence (55% of population), moderate steady (29%), late declining (8%), and early declining (9%). No baseline characteristics significantly differed between adherence patterns. Adherence patterns differed in average weekly doses (6.7 vs 5.4 vs 4.1 vs 1.5, respectively). Two risk behavior groups were identified: steady HIV risk (78% of population) and declining (22%). Compared to women with declining HIV risk behavior, women with steady risk behavior were more likely to have high steady adherence (61% vs 35%) and less likely to have early (6% vs 17%) or late (4% vs 19%) declining adherence. CONCLUSIONS: Women’s use of PrEP was associated with concurrent HIV risk behavior; higher risk was associated with higher, sustained adherence.

Detection and treatment of human papillomavirus (HPV) and cervical precancer through screening programs is an effective way to reduce cervical cancer deaths. However, high cervical cancer mortality persists in low- and middle-income countries. As screening programs become more widely available, it is essential to understand how knowledge about cervical cancer and perceived disease risk impacts screening uptake and acceptability. We evaluated women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya, as part of a cluster randomized controlled trial of cervical cancer screening implementation strategies. The educational modules employed simple language and images and sought to increase understanding of the relationship between HPV and cervical cancer, the mechanisms of self-collected HPV testing, and the importance of cervical cancer screening. Modules took place in three different contexts throughout the study: (1) during community mobilization; (2) prior to screening in either community health campaigns or health facilities; and (3) prior to treatment. Between January and September 2016, we conducted in-depth interviews with 525 participants to assess their experience with various aspects of the screening program. After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma. Some misconceptions about cervical cancer were evident. With effective and context-specific training, lay health workers, such as CHVs, can help bridge the gap between cervical cancer screening uptake and acceptability.

Introduction Partner notification services (PNS) increase the HIV status knowledge and linkage to care and treatment. However, it is unclear if PNS can facilitate linkage of HIV‐negative partners to prevention services such as pre‐exposure prophylaxis (PrEP). Using qualitative methods, we explored provider perspective regarding the interaction of PrEP availability, PNS and antiretroviral treatment (ART) outcomes within a project integrating PrEP services into HIV care clinics in eight counties in western and central Kenya. Methods From May 2017 to August 2018, data on integrated PrEP service delivery including its interaction with PNS were collected through 71 key informant in‐depth interviews with healthcare providers and 24 standardized technical assistance reports summarizing implementation at the participating clinics. Thus, the perspective was from that of providers; analyses focused on emergent themes relating PNS to PrEP and ART services. Results Providers found that PrEP integration provided an additional concrete prevention option for HIV‐negative partners and created a motivation to offer PNS to persons living with HIV. PrEP availability also seemed to operate as an incentive for those living with HIV to participate in PNS, which in turn enhanced identification of potential PrEP clients and created an environment for discussing HIV transmission risk. Providers commented that initiating HIV‐negative partners on PrEP enhanced mutual monitoring of health outcomes, including improved adherence to ART by partners living with HIV. Clinics noted prioritizing people living with HIV with detectable viral loads for PNS in order to identify HIV‐negative partners who would benefit most from PrEP. Providers felt motivated by the apparent synergistic interaction of PNS, PrEP and ART. Conclusions Providers felt that the integration of PrEP into HIV care clinics stimulated the provision of PNS, and PNS was used to improve the identification of potential PrEP clients. The integrated combination of PNS, PrEP and ART is synergistic and should be promoted in HIV clinics.

BACKGROUND: The data needed to understand the characteristics and outcomes, over time, of adolescents enrolling in HIV care in East Africa are limited. SETTING: Six HIV care programs in Kenya, Tanzania, and Uganda. METHODS: This retrospective cohort study included individuals enrolling in HIV care as younger adolescents (10–14 years) and older adolescents (15–19 years) from 2001–2014. Descriptive statistics were used to compare groups at enrollment and antiretroviral therapy (ART) initiation over time. The proportion of adolescents was compared with the total number of individuals aged 10 years and older enrolling over time. Competing-risk analysis was used to estimate 12-month attrition after enrollment/pre-ART initiation; post-ART attrition was estimated by Kaplan-Meier method. RESULTS: A total of 6344 adolescents enrolled between 2001 and 2014. The proportion of adolescents enrolling among all individuals increased from 2.5% (2001–2004) to 3.9% (2013–2014, P< 0.0001). At enrollment, median CD4 counts in 2001–2004 compared with 2013–2014 increased for younger (188 vs. 379 cells/ mm(3), P< 0.0001) and older (225 vs. 427 cells/mm(3), P< 0.0001) adolescents. At ART initiation, CD4 counts increased for younger (140 vs. 233 cells/mm(3), P< 0.0001) and older (64 vs. 323 cells/ mm(3), P< 0.0001) adolescents. Twelve-month attrition also increased for all adolescents both after enrollment/pre-ART initiation (4.7% vs. 12.0%, P< 0.001) and post-ART initiation (18.7% vs. 31.2%, P< 0.001). CONCLUSIONS: Expanding HIV services and ART coverage was likely associated with earlier adolescent enrollment and ART initiation but also with higher attrition rates before and after ART initiation. Interventions are needed to promote retention in care among adolescents.

To evaluate the effectiveness of the implementation of the adolescent package of care (APOC) training on adolescent viral suppression at Family AIDS CareEducation Services (FACES)-supported sites.The effect of APOC training was evaluated based on viral load suppression (1000 copies/mL) of 10-19-year-olds in 13 FACES-supported sites in six months before (January 2015-August 2016) and after (November 2015-March 2017) the APOC training for each site.Patient-level data were abstracted from the FACES electronic medical records (OpenMRS) and the National AIDS and STI Control Programme viral load website. Information on adolescent clinic day implementation and utilization of an APOC checklist as a proxy for services provided at each site was collected. Generalized estimating equations with repeated measures clustered by patients were used for bivariate and multivariate modeling to assess factors associated with viral suppression.In the pretraining period, 60% of adolescents received services at clinics offering adolescent clinic days compared to 95% in the post-training period. Among those tested, 65% were virally suppressed during the pretraining period compared to 72% during the post-training period (odds ratio [OR] = 1.31, 95% confidence interval [CI] 1.12, 1.53, P 0.01). In multivariable analysis, there was no statistically significant change in viral load suppression due to APOC training (adjusted OR [aOR] = 0.97, 95% CI: 0.72, 1.30, P = 0.84). However, at clinics offering adolescent-friendly clinic days, adolescents were nearly 2 times more likely to be virally suppressed than at facilities not offering these specialized clinic days (aOR = 1.86, 95% CI: 1.04, 3.32, P = 0.04).This study suggests that adolescent clinic days greatly improve adolescent viral load suppression and should be considered for implementation across HIV programs.

Human papillomavirus (HPV) is associated with ano-genital and cervical cancer. Persistence of oncogenic HPV genotypes is a requirement for development and progression of malignancies. Although,70% of women clear incident HPV infections, data on natural history and HPV immunology among men is limited. To evaluate cell-mediated immune responses to natural HPV infections among men, we assessed cytokine responses on PBMCs collected from men with persistent or cleared HPV. Men with HPV clearance and those with HPV persistence had increased odds (6-times and 3-times respectively) of mounting cytokine responses compared to HPV uninfected men. Th1 cytokines IFN-γ (5.1-fold) and IL-2 (4.2-fold) were significantly (p 0.0001) upregulated among men with HPV clearance compared to HPV uninfected men. Among men with HPV clearance compared to those with persistent HPV infection, only IFN-γ (2.4-fold) and IL-2 (3.0-fold) were significantly (p 0.0001) upregulated. Th1 cell-mediated cytokine response was associated with natural HPV clearance in men.

A rapid results initiative (RRI) aimed at increasing male involvement in prevention of mother-to-child transmission (PMTCT) and service uptake among pregnant women at 116 antenatal clinics in Western Kenya was compared at baseline, during the RRI, and 3-months post-RRI. Male involvement increased from 7.4 to 54.2% during RRI (risk difference [RD] 0.47, CI 0.45-0.48) then 43.4% post-RRI (RD 0.36, CI 0.35-0.37). Among HIV-infected women, facility delivery increased from 40.0 to 49.9% (RD 0.10, 95% CI 0.06-0.13) and 65.0% post-RRI (RD 0.25, 95% CI 0.22-0.28). HIV-infected pregnant women linkage to HIV care increased from 58.6 to 85.9% (RD 0.27, CI 0.24-0.30) and 97.3% post-RRI (RD 0.39, CI 0.36-0.41). Time to ART initiation reduced from 29days (interquartile range [IQR] 6-56) to 14days (IQR 0-28) to 7days (IQR 0-20). A male-centered RRI can significantly increase men's engagement in antenatal care leading to improved partner utilization of PMTCT and antenatal services.

OBJECTIVES: Pregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment. We assessed whether pregnancy lowers concentrations of tenofovir (TFV) and tenofovir-diphosphate (TFV-DP) among HIV-uninfected women using oral pre-exposure prophylaxis (PrEP). METHODS: We analyzed data from an open-label PrEP study, comparing concentrations of TFV in plasma and TFV-DP in dried blood spots (DBS) among 37 pregnant women and 97 non-pregnant women. Analyses controlled for adherence from daily electronic monitoring. RESULTS: The average plasma concentration of TFV among pregnant women was 34.7 ng/mL with 22.2 average recorded doses over the prior month versus 86.5 ng/mL with 23.1 doses among non-pregnant women. After controlling for adherence, TFV concentrations were 58% lower among pregnant women, a statistically significant difference of −50.4 ng/mL (95%CI −68.3 to −32.5). The average TFV-DP concentration was 450.3 fmol/punch among pregnant women and 636.7 fmol/punch among non-pregnant women. This difference was not statistically significant after adjusting for adherence; however, among those with quantifiable TFV-DP, concentrations were 27% lower during pregnancy (−202 fmol/punch [95%CI −384 to −19]). Among participants with samples before and during pregnancy, there were significant decreases during pregnancy, controlling for adherence: −28.1 ng/mL TFV (95%CI −52.3 to −4.0) and −289.2 fmol/punch TFV-DP (95%CI −439.0 to −139.3). CONCLUSIONS: Consistent with studies among HIV-infected women on ART, we found TFV and TFV-DP concentrations were lower during pregnancy. There is no established TFV concentration threshold to achieve HIV prevention. Additional pharmacokinetic studies and studies of PrEP efficacy in pregnancy are needed.

Author(s): Shade, Starley B; Osmand, Thomas; Luo, Alex; Aine, Ronald; Assurah, Elly; Mwebaza, Betty; Mwai, Daniel; Owaraganise, Asiphas; Mwangwa, Florence; Ayieko, James; Black, Douglas; Brown, Lillian B; Clark, Tamara D; Kwarisiima, Dalsone; Thirumurthy, Harsha; Cohen, Craig R; Bukusi, Elizabeth A; Charlebois, Edwin D; Balzer, Laura; Kamya, Moses R; Petersen, Maya L; Havlir, Diane V; Jain, Vivek | Abstract: OBJECTIVES/DESIGN:As antiretroviral therapy (ART) rapidly expands in sub-Saharan Africa using new efficient care models, data on costs of these approaches are lacking. We examined costs of a streamlined HIV care delivery model within a large HIV test-and-treat study in Uganda and Kenya. METHODS:We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records. Cost categories included salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs. We then modeled costs under three increasingly efficient scale-up scenarios: lowest-cost ART, centralized viral load testing, and governmental healthcare worker salaries. We assessed the relationship between community-specific ART delivery costs, retention in care, and viral suppression. RESULTS:Estimated streamlined HIV care delivery costs were $291/ppy. ART ($117/ppy for TDF/3TC/EFV [40%]) and viral load testing ($110/ppy for 2 tests/year [39%]) dominated costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs ($7/ppy). Optimized ART scale-up with lowest-cost ART ($100/ppy), annual viral load testing ($24/ppy), and governmental healthcare salaries ($27/ppy), lowered streamlined care cost to $163/ppy. We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression. CONCLUSIONS:In the SEARCH Study, streamlined HIV care delivery costs were similar to or lower than prior estimates despite including viral load testing; further optimizations could substantially reduce costs further. These data can inform global strategies for financing ART expansion to achieve UNAIDS 90-90-90 targets.

African HIV serodiscordant couples often desire pregnancy, despite sexual HIV transmission risk during pregnancy attempts. Pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) reduce HIV risk and can be leveraged for safer conception but how well these strategies are used for safer conception is not known. We conducted an open-label demonstration project of the integrated delivery of PrEP and ART among 1,013 HIV serodiscordant couples from Kenya and Uganda followed quarterly for 2 years. We evaluated fertility intentions, pregnancy incidence, the use of PrEP and ART during peri-conception, and peri-conception HIV incidence. At enrollment, 80% of couples indicated a desire for more children. Pregnancy incidence rates were 18.5 and 18.7 per 100 person years among HIV-uninfected and HIV-infected women, and higher among women who recently reported fertility intention (adjusted odds ratio=3.43, 95% CI 2.38-4.93) in multivariable GEE models. During the 6 months preceding pregnancy, 82.9% of couples used PrEP or ART and there were no HIV seroconversions. In this cohort with high pregnancy rates, integrated PrEP and ART was readily used by HIV serodiscordant couples, including during peri-conception periods. Widespread scale-up of safer conception counseling and services is warranted to respond to strong desires for pregnancy among HIV-affected men and women.