Search

In sub-Saharan Africa, sexually active adolescent girls and young women (AGYW) experience high rates of intimate partner violence (IPV) and low levels of contraceptive use, but the effect of IPV on contraceptive use is not well understood.In the Girl Power-Malawi study, AGYW aged 15-24 were recruited from 4 health centers in Lilongwe, Malawi, and followed for 1 year. At baseline, AGYW were assessed for IPV using the modified Conflict Tactics Scale. AGYW reported contraceptive method use at 6 and 12 months, characterized as barrier, non-barrier, or any modern method. Modified Poisson regression was implemented to estimate risk ratios (RRs) and 95% confidence intervals (CIs) to examine the effect of IPV on contraceptive use.One thousand AGYW were enrolled, and 954 non-pregnant participants were included. Baseline prevalence of IPV with the most recent partner was 35.5% (physical), 46.2% (sexual), and 76.9% (emotional). Baseline IPV did not affect contraceptive use at 6 months (aRR [95% CI]: physical 0.98 [0.91-1.05]; sexual 1.00 [0.94-1.07]; emotional 1.03 [0.94-1.12]) or 12 months (physical 0.95 [0.89-1.02]; sexual 0.96 [0.90-1.02]; emotional 0.98 [0.91-1.05]). None of the 3 IPV categories affected contraceptive use when the outcome was restricted to either barrier or non-barrier methods.In this cohort, IPV was not a key driver of contraceptive use in longitudinal analyses. Interventions are needed to address the alarming rates of IPV in this population, but addressing IPV alone might be insufficient to address low contraceptive use, and multifaceted youth-friendly health services might be necessary.

Though effective reproductive health interventions have been developed for adolescent girls and young women (AGYW) in sub-Saharan Africa, few have explored whether specific components of the interventions are responsible for observed changes in behaviour. Data for this longitudinal mediation analysis come from a quasi-experimental, sexual and reproductive health study conducted among AGYW (age 15-24) in Malawi. We assessed the extent to which the relationship between attending communication-specific small-group sessions and contraceptive use at one-year was mediated by contraceptive communication with partners at six months, using a bootstrapping procedure to estimate indirect effects. Of 358 participants, 44% attended communication-specific small-group sessions, 37% communicated with partners about contraception at six months, and 21% used non-barrier contraception at one-year. Participants who attended communication-specific small-group sessions had increased contraceptive communication with partners at six months (aOR = 1.48, 95% CI: 1.07-2.38) and increased non-barrier contraceptive use at one-year (aOR = 3.53, 95% CI: 1.86-6.69). The relationship between attending communication-specific small-group sessions and non-barrier contraceptive use at one-year was partially mediated by contraceptive communication with partners at six months (indirect effect = 0.04, 95% CI: 0.01-0.07). Our results suggest that contraceptive communication with partners is modifiable through interventions and important for AGYW non-barrier contraceptive uptake.

This study sought to explore and contextualise the man's role in antenatal services, and the barriers and strategies for engaging men in prevention of mother-to-child HIV transmission (PMTCT). We conducted 143 interviews with pregnant and breastfeeding women, male partners, health workers and policy makers in Malawi and Zambia. We employed thematic and critical discourse analysis using the hegemonic masculinity perspective. We found that men's roles in PMTCT reflected hegemonic masculinities. As breadwinners, men supported their partners with material and financial resources. As decision makers, men were involved in decision making on the health of their partners. As social protectors, men supported their partners in accessing and adhering to antenatal care, HIV treatment and care. Barriers and challenges to male involvement in antenatal care were often the result of conflict between the clinic operating hours and men's working hours, the perception of antenatal care services as female spaces, and men's fear of HIV testing. Proposed strategies to increase male engagement in PMTCT included sensitising men about HIV and pregnancy; engaging leaders and employers, providing services outside working hours, and providing incentives. We conclude that men's role and participation in PMTCT services are an extension and adaptation of hegemonic masculinities.

INTRODUCTION: Youth are often the intended beneficiaries of HIV programs but are rarely involved in program design. Engaging youth in program design is one potential way of identifying promising approaches for HIV service delivery. The purpose of this study is to examine the feasibility of using a crowdsourcing contest to solicit ideas on ways to promote HIV self-testing (HIVST) services among Nigerian youths. METHODS: From October-November, 2018 Nigerian youth 10–24 years old submitted ideas to a crowdsourcing contest on how to promote HIVST among their peers. Submissions were scored on feasibility, desirability, and impact, with an integer score of 1 (low) to 3 (high) in each domain. The three-domain scores were added to calculate a total score (3–9). The demographic characteristics of contestants were calculated using descriptive statistics. RESULTS: Nine-hundred and three entries were received, 831 had unique valid responses, and 769 were eligible for scoring. Youth submitted ideas on paper (44.9%), Google Forms (39.4%), WhatsApp (9.6%), and email (6.1%). Participants’ ages were 10–14 years (37%), 15–19 years (44%), and 20–24 years (22%).Approximately half were female (51.2%). Mean scores were 1.4/3.0 (SD=0.6) for feasibility, 1.4/3.0 (SD=0.6) for desirability, 1.2/3.0 (SD=0.5) for impact, and 4.0/9.0 (SD=1.5) overall. Eight percent of submissions had an overall score >7. A disproportionate share of these high-quality submissions came from email and Google submissions. CONCLUSION: The 4 Youth by Youth crowdsourcing contest engaged a broad audience and is a feasible way to elicit potential strategies to distribute HIVST kits to other youth. Several high-quality ideas require further evaluation.

In Malawi, 50% of adolescent girls and young women (AGYW) have had a first child by age 19 and 45% report their pregnancies as unintended or mistimed. Yet, uptake of contraception remains low. Understanding how interactions with social ties impact AGYW contraceptive use might explain low uptake beyond individual and environmental factors. Data are from Girl-Power, a study among sexually active AGYW, aged 15–24, in Malawi. We used logistic regression models to examine whether contraceptive communication and social norms (descriptive and injunctive) were associated with contraceptive use (non-barrier methods and condoms) and how associations differed across social ties (older women in the family, peers, and partners). The sample included 942 participants: 28% reported using non-barrier methods and 66% reported using condoms. Contraceptive communication with older women in the family (aOR: 1.48, 95% CI: 0.99, 2.20), peers (aOR: 3.12, 95% CI: 1.96, 4.96), and partners (aOR 5.15, 95% CI: 3.13, 8.48) was associated with non-barrier method use. Descriptive norms were associated with non-barrier methods among peers (aOR 2.57, 95% CI: 1.63, 4.96) but not among older women in the family (aOR: 1.22, 95% CI 0.80, 1.88). There were no associations among contraceptive communication, social norms, and condom use across older women in the family, peers, and partners. The findings highlight the need to consider the influence of social ties in the design of future family planning interventions and suggest that interventions that encourage interpersonal communication about contraception and target peer-based descriptive norms have the potential to impact uptake of non-barrier methods.

Transactional sex is associated with incident HIV infection among adolescent girls and young women (AGYW) in sub-Saharan Africa. Evidence on the dimensions of socioeconomic status (SES) which predict transactional sex are mixed and primarily come from cross-sectional studies. This study examined the association between SES and transactional sex in a longitudinal cohort (n = 844) of AGYW ages 15-24 years enrolled in a quasi-experimental study in Lilongwe, Malawi. Prevalence of transactional sex was 22% at baseline, 15% at 6-months and 20% at 12-months. Being divorced or widowed, being food insecure, living in a home without electricity or running water, and having few assets were associated with transactional sex. Higher educational attainment and school enrollment were protective. Having 6-7 socioeconomic risk factors increased odds of transactional sex (AOR = 4.13, 95% CI 2.45, 6.98). Structural interventions which address multiple dimensions of SES may reduce transactional sex and ultimately prevent HIV transmission among AGYW.

BACKGROUND HIV index testing, an intervention in which HIV-positive "indexes" (persons diagnosed with HIV) are supported to recruit their "contacts" (sexual partners and children) efficiently identifies HIV-infected persons in need of treatment and HIV-uninfected persons in need of prevention. However, index testing implementation in sub-Saharan African health care settings has been suboptimal. The objective of this study was to develop and pilot test a blended learning capacity-building package to improve index testing implementation in Malawi. METHODS In 2019, a blended learning package combining digital and face-to-face training modalities was field tested at 6 health facilities in Mulanje, Malawi using a pre-/post- type II hybrid design with implementation and effectiveness outcomes. Health care worker (HCW) fidelity to the intervention was assessed via observed encounters before and after the training. Preliminary effectiveness was examined by comparing index testing program indicators in the 2 months before and 4 months after the training. Indicators included the mean number of indexes screened, contacts elicited, and contacts who received HIV testing per facility per month. RESULTS On a 30-point scale, HCW fidelity to index testing protocols improved from 6.0 pre- to 25.5 post-package implementation (P = 0.002). Index testing effectiveness indicators also increased: indexes screened (pre = 63, post = 101, P < 0.001); contacts elicited (pre = 75, post = 131, P < 0.001); and contacts who received HIV testing (pre = 27, post = 41, P = 0.014). CONCLUSIONS The blended learning package improved fidelity to index testing protocols and preliminary effectiveness outcomes. This package has the potential to enhance implementation of HIV index testing approaches, a necessary step for ending the HIV epidemic.

Summary Background Testing men for HIV during their partner's pregnancy can guide couples-based HIV prevention and treatment, but testing rates remain low. We investigated a combination approach, using evidence-based strategies, to increase HIV testing in male partners of HIV-positive and HIV-negative pregnant women. Methods We did two parallel, unmasked randomised trials, enrolling pregnant women who had an HIV-positive test result documented in their antenatal record (trial 1) and women who had an HIV-negative test result documented in their antenatal record (trial 2) from an antenatal setting in Lusaka, Zambia. Women in both trials were randomly assigned (1:1) to the intervention or control groups using permuted block randomisation. The control groups received partner notification services only, including an adapted version for women who were HIV-negative; the intervention groups additionally received targeted education on the use of oral HIV self-test kits for their partners, along with up to five oral HIV self-test kits. At the 30 day follow-up we collected information from pregnant women about their primary male partner's HIV testing in the previous 30 days at health-care facilities, at home, or at any other facility. Our primary outcome was reported male partner testing at a health facility within 30 days following randomisation using a complete-case approach. Women also reported male partner HIV testing of any kind (including self-testing at home) that occurred within 30 days. Randomisation groups were compared via probability difference with a corresponding Wald-based 95% CI. The trial is registered at ClinicalTrials.gov ( NCT04124536 ) and all enrolment and follow-up has been completed. Findings From Oct 28, 2019, to May 26, 2020, 116 women who were HIV-positive (trial 1) and 210 women who were HIV-negative (trial 2) were enrolled and randomly assigned to study groups. Retention at 30 days was 100 (86%) in trial 1 and 200 (95%) in trial 2. Women in the intervention group were less likely to report facility-based male partner HIV testing in trial 1 (3 [6%] of 47 vs 15 [28%] of 53, estimated probability difference –21·9% [95% CI –35·9 to –7·9%]) and trial 2 (3 [3%] of 102 vs 33 [34%] of 98, estimated probability difference –30·7% [95% CI –40·6 to –20·8]). However, reported male partner HIV testing of any kind was higher in the intervention group than in the control group in trial 1 (36 [77%] of 47 vs 19 [36%] of 53, estimated probability difference 40·7% [95% CI 23·0 to 58·4%]) and trial 2 (80 [78%] of 102 vs 54 [55%] of 98, estimated probability difference 23·3% [95% CI 10·7 to 36·0%]) due to increased use of HIV self-testing. Overall, 14 male partners tested HIV-positive. Across the two trials, three cases of intimate partner violence were reported (two in the control groups and one in the intervention groups). Interpretation Our combination approach increased overall HIV testing in male partners of pregnant women but reduced the proportion of men who sought follow-up facility-based testing. This combination approach might reduce linkages to health care, including for HIV prevention, and should be considered in the design of comprehensive HIV programmes. Funding National Institutes of Health.

Transactional sex increases HIV risk among adolescent girls and young women (AGYW). Understanding the individual and dyadic nature of transactional sex may provide evidence for risk reduction interventions. Multilevel logistic regression was used to cross-sectionally examine correlates of transactional sex among AGYW in Lilongwe, Malawi. Participants (N = 920) reported 1227 relationships. Individual-level associations were found between being divorced/widowed (AOR 5.07, 95% CI 1.93, 13.25), married (AOR 0.26, 95% CI 0.09, 0.72), or unstably housed (AOR 7.11, 95% CI 2.74, 18.47) and transactional sex. At the relationship-level, transactional sex occurred in relationships with: non-primary primary partners (AOR 4.06, 95% CI 2.37, 6.94), perceived partner concurrency (AOR 1.85, 95% CI 1.11, 3.08), and feared violence with couples HIV testing (AOR 2.81, 95% CI 1.26, 6.29), and less likely to occur in relationships with children (AOR 0.15, 95% CI 0.06, 0.38). Multiple co-occurring social and structural vulnerabilities increase transactional sex engagement warranting the need for social protection and gender transformative approaches.

This analysis estimates prevalence of intimate partner violence (IPV) and its association with probable depression among adolescent girls and young women (AGYW) in Lilongwe, Malawi, and whether partner's controlling behaviour modifies this relationship. Baseline data was utilised from the Girl Power-Malawi study of 1000 15-24-year-old AGYW in Lilongwe. Emotional, physical, and sexual IPV experiences with a current or recent partner were measured using the modified Conflict Tactics Scale. Probable depression was measured by scoring ≥10 on the Centre for Epidemiologic Studies-Short Depression Scale (CES-D-10). Generalised linear models with log-link and binomial distribution estimated prevalence ratios (PR) and 95% confidence intervals (CI) for the association between IPV types and probable depression. Partner's controlling behaviour was examined as an effect modifier. Participants' mean age was 19.2 years, with 70% never-married. IPV prevalence varied for emotional (59%), physical (36%), sexual (46%), and all forms (20%). Prevalence of probable depression was 47%. AGYW who experienced each IPV type had a higher prevalence of probable depression: physical (PR:1.54, CI:1.28-1.86), sexual (1.46, CI:1.21-1.75), emotional (1.37, CI:1.14-1.64), all forms (1.72, CI:1.41-2.09). IPV and probable depression were prevalent and strongly associated, especially among AGYW reporting controlling behaviour. Interventions addressing IPV and controlling behaviour may positively impact depression among AGYW.

Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of many adverse sexual and reproductive health outcomes. Small-group interventions addressing underlying vulnerabilities may influence risky sexual behaviors associated with these adverse outcomes. Girl Power-Malawi assessed whether a facilitator-led, curriculum-driven small-group behavioral intervention impacted risky sexual behaviors among AGYW in Lilongwe, Malawi. Four Health Centers were selected; two were randomly assigned to provide the intervention. Two-hundred fifty AGYW 15–24 years old were enrolled in each clinic (N=1000 total), followed for one year, and interviewed at baseline and endline. At both time points participants reported on two behaviors in the last month (vaginal sex and ≥2 sexual partners) and two behaviors in the last year (age-disparate relationships and transactional relationships). In intervention clinics, there were no declines in risk behaviors between baseline and endline. Endline behaviors were not less risky in intervention clinics than control clinics. This intervention did not have a positive effect on four risk behaviors over a one-year period.

Adherence self-efficacy, belief in one’s ability to adhere to daily medication, is strongly associated with antiretroviral therapy (ART) adherence and preventing mother-to-child HIV transmission. Couple-based interventions could enhance self-efficacy and adherence. We assessed the relationship between couple HIV testing and counseling (cHTC) and adherence self-efficacy using a 100-point culturally-adapted adherence self-efficacy scale (ASES). Secondarily, we explored the relationship between ASES and ART adherence. Ninety HIV-positive pregnant women at an antenatal clinic in Lilongwe, Malawi were enrolled in an observational cohort study. They were assessed with ASES immediately before and one month after receiving cHTC. Median ASES scores were 100 (IQR 95, 100) before and 100 (IQR 99, 100) after cHTC; there was a significant median difference (p = 0.02) for participants before and after cHTC. This change in ASES scores was associated with the odds of self-reported ART adherence in the full population (OR 1.1, p = 0.01), and there was a trend in the same direction for participants with imperfect baseline ASES scores (OR 1.1, p = 0.2). In our population, adherence self-efficacy and ART adherence were both quite high, and those who had room to improve in self-efficacy may have benefited from cHTC, which in turn could impact ART adherence and ultimately mother-to-child transmission.

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is (1) to analyse a prototypical cluster trial conducted in a low-resource setting (PURE Malawi trial) with the Ottawa Statement; (2) to identify ethical issues in the design or conduct of the trial not captured adequately and (3) to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: (1) streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; (2) the classification of lay health workers who deliver study interventions as health providers or research participants; (3) the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; (4) the timing of gatekeeper engagement, particularly when researchers face funding constraints; (5) providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and (6) defining vulnerable participants needing protection in low-resource settings.

IntroductionTo realise the expected gains from prevention of mother-to-child HIV transmission initiatives, adherence to preventative and therapeutic antiretroviral regimens is critical and interventions deployable in busy programmatic settings with a high HIV burden are needed. Based on formative research, we developed an approach that integrates patient-centred counselling and engagement of an adherence supporter for pregnant and breastfeeding women initiating HIV treatment (ie, antiretroviral therapy (ART)) or biomedical HIV prevention (ie, pre-exposure prophylaxis (PrEP)).MethodsTonse Pamodzi 2 is a pilot study designed to provide acceptability, fidelity and clinical outcomes data on a set of behavioural interventions for adherence support. The study comprises two parallel randomised trials, enrolling HIV-positive pregnant women initiating ART (Trial 1, n=100) and HIV-negative pregnant women with risk of HIV acquisition and willing to initiate PrEP (Trial 2, n=200). Within each trial, participants are randomised 1:1 to either the intervention or control group. The Tonse Pamodzi adherence intervention comprises patient-centred counselling (adapted Integrated Next Step Counseling(iNSC)) and external adherence support tailored to the clinical context (ie, for ART or PrEP). Participants randomly assigned to the control group receive standard counselling based on local HIV guidelines. Participants are followed for 6 months. To assess intervention acceptability, we will employ a mixed method approach to describe participant engagement, satisfaction, and discussion content. We will audit and score recorded counselling sessions to evaluate the implementation fidelity of iNSC sessions. We will also assess clinical outcomes at 3 and 6 months for both Trial 1 (retention in care and viral suppression of HIV) and Trial 2 (retention in care, and plasma and intracellular tenofovir drug concentrations).Ethics and disseminationThe study protocol was approved by the Malawi National Health Science Research Committee (19/05/2334) and the University of North Carolina at Chapel Hill Institutional Review Board (19-1060).Trial registration numberNCT04330989.

Introduction Long-term care engagement of women on antiretroviral therapy (ART) is essential to effective HIV public health measures. We sought to explore factors associated with a history of HIV treatment interruption among pregnant women living with HIV presenting to an antenatal clinic in Lilongwe, Malawi. Methods We performed a cross-sectional study of pregnant women living with HIV who had a history of ART interruption presenting for antenatal care. Women were categorized as either retained in HIV treatment or reinitiating care after loss-to-follow up (LTFU). To understand factors associated with treatment interruption, we surveyed socio-demographic and partner relationship characteristics. Crude and adjusted prevalence ratios (aPR) for factors associated with ART interruption were estimated using modified Poisson regression with robust variance. We additionally present patients’ reasons for ART interruption. Results We enrolled 541 pregnant women living with HIV (391 retained and 150 reinitiating). The median age was 30 years (interquartile range (IQR): 25–34). Factors associated with a history of LTFU were age Conclusions Interventions that simplify the ART clinic transfer process, facilitate partner disclosure, and provide counseling about the importance of lifelong ART beyond pregnancy and breastfeeding should be further evaluated for improving retention in ART treatment of women living with HIV in Malawi.

Introduction Youth engagement in HIV research is generally recognized as essential, but often neglected or minimally implemented in practice. Engagement is a process of working collaboratively with diverse groups of people to address common issues. We conducted a scoping review of youth HIV prevention interventions in sub‐Saharan Africa to identify and categorize forms and levels of youth engagement across the lifespan of intervention research. Methods We followed Arksey and O'Malley's framework for organizing a scoping review. We searched seven databases for related articles on identified intervention studies through May 28th 2020. Included studies focused on youth (10 to 24 years old) HIV prevention interventions in sub‐Saharan Africa. Two reviewers independently examined citations and full manuscripts for inclusion. Data were extracted on study characteristics, location, description of youth engagement and extent of engagement. Youth engagement approaches were categorized based on Hart’s ladder as substantial engagement (strong youth decision‐making power), moderate engagement (shared decision making with adults), minimal engagement (no youth decision‐making power) or no engagement. Results We identified 3149 citations and included 112 studies reporting on 74 unique HIV interventions. Twenty‐two interventions were in low‐income countries, 49 in middle‐income countries, and three were in both. Overall, only nine interventions (12%) had substantial or moderate youth engagement, two‐thirds (48, 65%) had minimal youth engagement and 17 interventions (23%) had no youth engagement. We also identified specific engagement strategies (e.g. youth‐led research, crowdsourcing) that were feasible in multiple settings and resulted in substantial engagement. Conclusions We found limited youth engagement in youth HIV prevention intervention studies in sub‐Saharan Africa. However, several activities resulted in substantial youth engagement and could be relevant in many low‐and‐middle‐income‐country (LMIC) settings.

To eliminate mother-to-child transmission of HIV (EMTCT), scalable strategies to enhance antiretroviral adherence for both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed as part of integrated HIV and maternal-child health services. We developed Tonse Pamodzi (“all of us together”), an adaptable intervention integrating biomedical and behavioral components to support HIV treatment and prevention. We describe our intervention development process, which comprised formative qualitative research, a review of the literature, and technical input from stakeholders representing the community, health systems, and policymakers. The resulting intervention, described herein, integrates patient-centered counseling and engagement of a patient-selected adherence supporter for pregnant and breastfeeding women initiating ART or PrEP. Patients receiving the intervention engage in Integrated Next Step Counseling (iNSC) sessions delivered by trained counselors to build and maintain adherence skills. Each patient also has the option of selecting an adherence supporter (partner, family member, or friend) who may participate in iNSC sessions and provide adherence support outside of these sessions. This flexible intervention is adaptable not only to ART or PrEP use, but also to the needs and preferences of each woman and the clinical context. If shown to be acceptable and feasible, the Tonse Pamodzi intervention may be an important tool in continuing efforts for EMTCT.

BACKGROUND Despite the global expansion of HIV self-testing (HIVST), many research studies still rely on self-reported outcomes. New HIVST verification methods are needed, especially in resource-limited settings. OBJECTIVE This study aims to evaluate the user experience of a mobile health (mHealth) app to enhance HIVST result reporting and verification. METHODS Semistructured, in-depth interviews were used to evaluate the user experience of the 4 Youth By Youth mHealth photo verification app for HIVST. We used a think-aloud approach, and participants performed usability tasks and completed a qualitative exit interview. The app included HIV educational resources, step-by-step video instructions for performing HIVST, a 20-minute timer, a guide on interpreting results with linkages to care, an offline version, and a photo verification system. Demographic characteristics were reported by using descriptive statistics. Qualitative data were analyzed by using thematic analysis. RESULTS A total of 19 users—12 women and 7 men—with a mean age of 22 years, participated in the study. The users completed the usability tasks and successfully uploaded a photo of their test results by using the app without assistance. Four main themes were identified in the data. First, in terms of user-friendly design, the participants noted the user-friendly features of the offline version and the app’s low data use. However, some wanted the app to work in the background when using their mobile phone, and the font used should be more youth friendly. Second, in terms of ease of use, participants remarked that the app’s self-explanatory nature and instructions that guided them on how to use the app enhanced its use. Third, in terms of a user’s privacy, many participants reinforced the importance of privacy settings and tools that protect confidentiality among users. Finally, in terms of linkage to care, participants noted that the app’s linkage to care features were useful, particularly in relation to referrals to trained counselors upon the completion of the test. All the participants noted that the app provided a convenient and private means of verifying the HIV test results. CONCLUSIONS Our findings demonstrated the importance of engaging end users in the development phase of health technology innovations that serve youth. Clinical trials are needed to determine the efficacy of using an mHealth app to verify HIVST results among young people.

BACKGROUND: Prioritizing HIV prevention for adolescent girls and young women (AGYW) at high risk of HIV acquisition in sub-Saharan Africa (typically considered ≥3 per 100 person years [PYs]) is urgently needed, but identifying these AGYW is challenging. We sought to assess and, if needed, enhance a risk assessment tool from the VOICE trial for identifying AGYW at high risk for HIV in Lilongwe, Malawi. METHODS: A multisite prospective cohort study was conducted among sexually active AGYW 15–24 years old at four health centers in 2016–2017. The VOICE tool was first applied and then updated by excluding variables that were not predictive and adding variables that were. Incidence rates (IR), incidence rate ratios (IRR), ninety-five percent confidence intervals (CIs), area under the receiver-operator characteristic curve (AUC), sensitivity, and specificity were calculated. RESULTS: Seven-hundred ninety-five participants experienced 14 seroconversions over 672 person-years (IR: 2.08 per 100 PYs, CI: 1.23–3.52). The VOICE tool had moderate predictive ability (AUC: 0.64, CI: 0.52, 0.75). Maintaining two variables (genital ulcers and vaginal discharge), removing five socio-demographic variables, and adding two variables (ever pregnant and >5 year male-female age gap) enhanced performance (AUC=0.79, 95% CI: 0.69–0.89). Thirty-five percent had a score of 0, 41% had a score of 1–2, and 24% had a score ≥3. A score ≥1 resulted in 100% sensitivity, 35.9% specificity, and an IR of 3.25 per 100 PYs. A score ≥3 resulted in 64.3% sensitivity, 76.8% specificity, and an IR of 5.89 per 100 PYs. CONCLUSIONS: A simple risk assessment tool identified a subset of AGYW in Malawi at high risk of HIV acquisition who may benefit from biomedical HIV prevention.

Background Youth are at high risk for HIV, but are often left out of designing interventions, including those focused on adolescents. We organized a designathon for Nigerian youth to develop HIV self-testing (HIVST) strategies for potential implementation in their local communities. A designathon is a problem-focused event where participants work together over a short period to create and present solutions to a judging panel. Methods We organized a 72-h designathon for youth (14–24 years old) in Nigeria to design strategies to increase youth HIVST uptake. Proposals included details about HIVST kit service delivery, method of distribution, promotional strategy, and youth audience. Teams pitched their proposals to a diverse seven-member judging panel who scored proposals based on desirability, feasibility, potential impact and teamwork. We examined participants’ socio-demographic characteristics and summarized themes from their HIVST proposals. Results Forty-two youth on 13 teams participated in the designathon. The median team size was 3 participants (IQR: 2–4). The median age was 22.5 years (IQR: 21–24), 66.7% were male, 47.4% completed tertiary education, and 50% lived in Lagos State. Themes from proposals included HIVST integration with other health services, digital marketing and distribution approaches, and engaging students. Judges identified seven teams with exceptional HIVST proposals and five teams were supported for further training. Conclusions The designathon provided a structured method for incorporating youth ideas into HIV service delivery. This approach could differentiate HIV services to be more youth-friendly in Nigeria and other settings.

Introduction As a user‐controlled HIV prevention method, oral pre‐exposure prophylaxis (PrEP) holds particular promise for adolescent girls and young women (AGYW). HIV prevention cascades, critical frameworks for the design and evaluation of PrEP programmes, outline the priorities of identifying individuals at greatest HIV risk and motivating them to initiate PrEP through perceived HIV risk. To inform future iterations of these cascades and PrEP delivery for AGYW, the objective of this study was to understand the level of interest in PrEP among AGYW at highest HIV risk, and the potential role of perceived risk in motivating PrEP interest. Methods Using data from a cohort study of HIV‐negative AGYW in Lilongwe, Malawi (February 2016 to August 2017), we assessed the relationship between epidemiologic HIV risk (risk index developed in a previous analysis) and PrEP interest, and the extent to which perceived risk explains the relationship between HIV risk and PrEP interest. We further aimed to operationalize the pre‐initiation steps of the HIV prevention cascade in the study population. Results In total, 825 AGYW were included in analyses, of which 43% met the criterion for high epidemiologic HIV risk. While epidemiologic risk scores were positively associated with PrEP interest, high numbers of AGYW both above and below the high‐risk cutoff were very interested in PrEP (68% vs. 63%). Perceived risk partially explained the relationship between HIV risk and PrEP interest; greater epidemiologic HIV risk was associated with high perceived risk, which was in turn associated with PrEP interest. Many more high‐risk AGYW were interested in PrEP (68%) than expressed a high level of perceived HIV risk (26%). Conclusions These results highlight key relationships between epidemiologic HIV risk, risk perception and interest in PrEP. While risk perception did partially explain the relationship between epidemiologic risk and PrEP interest, there may be other important motivational mechanisms that are not captured in many HIV prevention cascades. The high number of participants with risk scores below the high‐risk cutoff who both expressed high perceived risk and interest in PrEP suggests that demand for PrEP among AGYW may not be well aligned with epidemiologic risk.

HIV self-testing (HIVST) allows individuals to interpret and report their own test results, thus decentralizing testing. Yet, this decentralization can make it difficult to verify self-testing results, which is important for linkage to care and surveillance. The aim of this systematic review is to summarize methods for verifying HIVST use and results. We followed guidance from the Cochrane Handbook 5.1 on systematic reviews. We searched four journal databases (PubMed, Embase, Scopus, and Cochrane Library), one clinical trials database (ClinicalTrials.gov), two conference abstract databases (International AIDS Society and Conference on Retroviruses and Opportunistic Infections) and one gray literature database (OpenGrey). We included studies that verified opening of kits or test results. Two researchers independently screened articles and extracted data regarding HIVST location, method of verification, who performed verification, proportion of results verified, and primary or secondary kit distribution. The search yielded 3853 unique citations, of which 40 contained information on HIVST verification and were included. Among these 40 studies, 13 were in high-income countries, 16 were in middle-income countries, and 11 were in low-income countries. Seventeen studies included key populations and two focused on youth. Three methods verified results: supervision by a health provider, returning used test kits, and electronic transmission of photographs. One method verified opening of kits using Bluetooth sensors. Although HIVST has increased worldwide, strategies to verify self-testing results remain limited. These findings suggest a need for additional innovative strategies for verifying HIVST use and results and linkage of self-testing results to surveillance and care systems.

BACKGROUND: The World Health Organization recommends HIV self-testing (HIVST) as an additional approach to HIV testing and the Nigerian government is supportive of this policy recommendation. However, effectively increasing uptake and sustainability among Nigerian youth is unknown. The goal of this study is to conduct a full-powered type I hybrid effectiveness-implementation trial to test the effectiveness of youth-friendly implementation science strategies in increasing uptake and sustainability of HIVST led by and for Nigerian youth. METHODS: Our 4 Youth by Youth (4YBY) strategy combines four core elements: 1) HIVST bundle consisting of HIVST kits and photo verification system; 2) a participatory learning community; 3) peer to peer support and technical assistance; and 4) on-site supervision and performance feedback to improve uptake and sustainability of HIVST and enhance linkage to youth-friendly health clinics for confirmatory HIV testing where needed, sexually transmitted infection (STI) testing (i.e. syphilis, gonorrhea, chlamydia, and hepatitis, STI treatment, and PrEP referral. Utilizing a stepped-wedge, cluster-randomized controlled trial, a national cohort of youth aged 14–24 recruited from 32 local government areas across 14 states and four geo-political zones in Nigeria will receive the 4YBY implementation strategy. In addition, an economic evaluation will explore the incremental cost per quality adjusted life year gained. DISCUSSION: This study will add to the limited “how-to-do it literature” on implementation science strategies in a resource-limited setting targeting youth population traditionally underrepresented in implementation science literature. Study findings will also optimize uptake and sustainability of HIVST led by and for young people themselves. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov NCT04710784 (on January 15, 2021).

BACKGROUND Adolescent girls and young women (AGYW) in sub-Saharan Africa have high HIV prevalence and incidence. We sought to understand which HIV risk factors individually and in combination contribute to risk, and whether these factors are associated with HIV worry and risk perception. SETTING This study is ongoing at 4 public health centers in Lilongwe, Malawi (2016-2017). METHODS AGYW of 15-24 years old were recruited to participate in a study assessing 4 models of service delivery. At each health center, participants completed a baseline survey assessing socioeconomic, behavioral, biomedical, and partnership characteristics; self-reported HIV status; and, if HIV-uninfected, HIV risk perception (high versus low or none) and HIV worry (any versus none). We analyzed associations between baseline characteristics and HIV prevalence, risk perception, and worry. RESULTS Among 1000 AGYW, median age was 19 years (IQR: 17-21). Thirty-three participants reported being HIV-infected. Fifteen characteristics were associated with HIV infection. Having more risk factors was associated with higher HIV prevalence (≤4 factors, 0.5%; 5-8 factors, 6%; >8 factors, 21%). Having more risk factors was also associated with higher risk perception (P < 0.001) and higher worry (P < 0.001). However, among those with ≥8 risk factors, 52% did not consider themselves to be at high risk and 21% did not report any HIV worry. CONCLUSIONS Most AGYW perceive little risk of HIV acquisition, even those at highest risk. As a critical gap in the HIV prevention cascade, accurate risk perception is needed to tailor effective and sustained combination prevention strategies for this vulnerable population.

We aimed to understand drivers of HIV-infection in pregnant women in Malawi. The study was conducted in antenatal and labor and delivery wards. HIV-infected women and their partners (cases) were frequency matched in a 1:2 ratio based on age and screening location to HIV-uninfected women and their partners (controls) in a prevalent case-control study. Characteristics associated with female HIV infection were assessed using logistic regression modeling. At screening, HIV-infected women were more likely to have partners outside Lilongwe than HIV-uninfected women (24% versus 0%, p2 lifetime marriages (OR=9.0, CI=2.6-30.9) or >3 lifetime partners (OR=18.0, CI=3.1-103.6) and lower if either reported past couple HIV testing and counseling (OR=0.1, CI=0.04-0.3). Targeting women with migrating partners, promoting couple HIV testing and counseling, and limiting partners could slow HIV transmission

BACKGROUND In sub-Saharan Africa couple HIV testing and counseling (CHTC) has been associated with substantial increases in safe sex, especially when at least one partner is HIV infected. However, this relationship has not been characterized in an Option B+ context. SETTING The study was conducted at the antenatal clinic at Bwaila District Hospital in Lilongwe, Malawi in 2016 under an Option B+ program. METHODS Ninety heterosexual couples with an HIV-infected pregnant woman (female-positive couples) and 47 couples with an HIV-uninfected pregnant woman (female-negative couples) were enrolled in an observational study. Each couple member was assessed immediately before and 1 month after CHTC for safe sex (abstinence or consistent condom use in the last month). Generalized estimating equations were used to model change in safe sex before and after CHTC and to compare safe sex between female-positive and female-negative couples. RESULTS Mean age was 26 years among women and 32 years among men. Before CHTC, safe sex was comparable among female-positive couples (8%) and female-negative couples (2%) [risk ratio (RR): 3.7, 95% confidence interval (CI): 0.5 to 29.8]. One month after CHTC, safe sex was higher among female-positive couples (75%) than among female-negative couples (3%) (RR: 30.0, 95% CI: 4.3 to 207.7). Safe sex increased substantially after CTHC for female-positive couples (RR 9.6, 95% CI: 4.6 to 20.0), but not for female-negative couples (RR: 1.2, 95% CI: 0.1 to 18.7). CONCLUSIONS Engaging pregnant couples in CHTC can have prevention benefits for couples with an HIV-infected pregnant woman, but additional prevention approaches may be needed for couples with an HIV-uninfected pregnant woman.

BACKGROUND In 2011, Malawi launched Option B+, a program of universal antiretroviral therapy (ART) treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6-month HIVRNA suppression and HIV drug resistance in the PURE study. METHODS PURE study was a cluster-randomized controlled trial evaluating 3 strategies for promoting uptake and retention; arm 1: Standard of Care, arm 2: Facility Peer Support, and arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution. RESULTS We enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant (86%) and were WHO stage 1 (95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted, and 699/833 (84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N = 55, 41% of all viral loads > 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the nonnucleoside reverse transcriptase inhibitor class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status. CONCLUSIONS Virologic suppression at 6 months was

Objectives Evaluation of a novel index case-finding and linkage-to-care program to identify and link HIV-infected children (1-15 years) and young adults (>15-24 years) to care. Methods HIV-infected patients enrolled in HIV services were screened and those who reported untested household members (index cases) were offered home or facility-based HIV testing and counseling (HTC) of their household by a community health worker (CHW). HIV-infected household members identified were enrolled in a follow-up program offering home and facility-based follow-up by CHWs. Results Of the 1567 patients enrolled in HIV services, 1030 (65.7%) were screened and 461 (44.8%) identified as index cases. 93.5% consented to HIV testing of their households and of those, 279 (64.7%) reported an untested child or young person. CHWs tested 711 children and young adults, newly diagnosed 28 HIV-infected persons (yield 4.0%; 95% CI: 2.7-5.6), and identified an additional two HIV-infected persons not enrolled in care. Of the 30 HIV-infected persons identified, 23 (76.6%) were linked to HIV services. 18 of the 20 eligible for ART (90.0%) were initiated. Median time (IQR) from identification to enrollment into HIV services was 4 days (1-8) and from identification to ART start was 6 days (1-8). Conclusions Almost half of HIV-infected patients enrolled in treatment services had untested household members, many of whom were children and young adults. Index case-finding, coupled with home-based testing and tracked follow-up is acceptable, feasible, and facilitates the identification and timely linkage to care of HIV-infected children and young adults. This article is protected by copyright. All rights reserved.

ntroduction: Malawi has embarked on a “test-and-treat” approach to prevent mother-to-child transmission (PMTCT) of HIV, known as “Option B+,” offering all HIV-infected pregnant and breastfeeding women lifelong antiretroviral therapy (ART) regardless of CD4 count or clinical stage. A cross-sectional qualitative study was conducted to explore early experiences surrounding “Option B+” for patients and health care workers (HCWs) in Malawi. Methods: Study participants were purposively selected across 6 health facilities in 3 regional health zones in Malawi. Semi-structured interviews were conducted with women enrolled in “Option B+” (n = 24), and focus group discussions were conducted with HCWs providing Option B+ services (n = 6 groups of 8 HCWs). Data were analyzed using a qualitative thematic coding framework. Results: Patients and HCWs identified the lack of male involvement as a barrier to retention in care and expressed concerns at the rapidity of the test-and-treat process, which makes it difficult for patients to “digest” a positive diagnosis before starting ART. Fear regarding the breach of privacy and confidentiality were also identified as contributing to loss to follow-up of women initiated under the Option B+. Disclosure remains a difficult process within families and couples. Lifelong ART was also perceived as an opportunity to plan future pregnancies. Conclusions: As “Option B+” continues to be rolled out, novel interventions to support and retain women into care must be implemented. These include providing space, time, and support to accept a diagnosis before starting ART, engaging partners and families, and addressing the need for peer support and confidentiality.

Malawi's Option B+ program provides all HIV-infected pregnant women free lifelong antiretroviral therapy (ART), but challenges remain regarding retention and ART adherence, potentially due to male partner barriers. We explored relationships between male partner involvement and Option B+ retention and adherence. In 2014, a randomized controlled trial in Malawi compared male recruitment strategies for couple HIV testing and counseling (cHTC) at an antenatal clinic. This secondary analysis was conducted among the entire cohort (N = 200) of women, irrespective of randomization status. We assessed whether cHTC attendance, early disclosure of HIV-positive status, and partner ART reminders were associated with retention and adherence at one month after starting treatment. Retention was defined as attending HIV clinic follow-up within one day of running out of pills. Adherence was defined as taking ≥95% of ARTs by pill count. We used binomial regression to calculate adjusted risk ratios (aRR) and 95% confidence intervals (CI). Median female age was 26 years. Most women (79%) were retained; of these, 68% were adherent. Receiving cHTC was associated with improved retention (aRR 1.33, 95% CI 1.12, 1.59). Receiving male partner ART reminders was weakly associated with retention (aRR 1.16, 95% CI 0.96, 1.39). Disclosure within one day was not associated with retention (aRR 1.08, 95% CI: 0.91, 1.28). Among those who were retained, these three behaviors were not associated with improved 95% adherence. CHTC could play an important role in improving Option B+ retention. Increasing cHTC participation and enhancing adherence-related messages within cHTC are important.

Objectives A previous meta-analysis reported high HIV incidence among pregnant and breast-feeding women in sub-Saharan Africa (SSA), but limited evidence of elevated risk of HIV acquisition during pregnancy or breast-feeding when compared with nonpregnant periods. The rapidly evolving HIV prevention and treatment landscape since publication of this review may have important implications for maternal HIV incidence. Design Systematic review and meta-analysis. Methods We searched four databases and abstracts from relevant conferences through 1 December 2018, for literature on maternal HIV incidence in SSA. We used random-effects meta-analysis to summarize incidence rates and ratios, and to estimate 95% prediction intervals. We evaluated potential sources of heterogeneity with random-effects meta-regression. Results Thirty-seven publications contributed 100 758 person-years of follow-up. The estimated average HIV incidence rate among pregnant and breast-feeding women was 3.6 per 100 person-years (95% prediction interval: 1.2--11.1), while the estimated average associations between pregnancy and risk of HIV acquisition, and breast-feeding and risk of HIV acquisition, were close to the null. Wide 95% prediction intervals around summary estimates highlighted the variability of HIV incidence across populations of pregnant and breast-feeding women in SSA. Average HIV incidence appeared associated with age, partner HIV status, and calendar time. Average incidence was highest among studies conducted pre-2010 (4.1/100 person-years, 95% prediction interval: 1.1--12.2) and lowest among studies conducted post-2014 (2.1/100 person-years, 95% prediction interval: 0.7--6.5). Conclusion Substantial HIV incidence among pregnant and breast-feeding women in SSA, even in the current era of combination HIV prevention and treatment, underscores the need for prevention tailored to high-risk pregnant and breast-feeding women.

BackgroundOral Pre-Exposure Prophylaxis (PrEP) is an effective HIV prevention strategy for adherent users. Adolescent girls and young women (AGYW) in sub-Saharan Africa may particularly benefit from PrEP because of the disproportionate burden of HIV in this group. Understanding potential users' perceptions of and interest in using PrEP is critical to promote the utilization of PrEP by individuals at risk of HIV.MethodsThis qualitative investigation of AGYW's knowledge of and interest in PrEP use was conducted in the context of Girl Power, a quasi-experimental cohort study comparing four models of service delivery at four health centers in Lilongwe, Malawi. We conducted individual in-depth interviews (IDIs) with 40 HIV-negative AGYW ages 15-24 years old six months after enrolment in the parent study. An explanation of PrEP was provided to participants. Interview topics included participants' prior knowledge of, interest in, concerns about, and delivery preferences for PrEP. Analysis consisted of structural coding of interview transcripts corresponding to interview topics, summary of responses within these topics, and identification and description of emerging themes within each topic.ResultsNone of the AGYW had knowledge of PrEP prior to the IDIs, but once explained, a majority expressed an interest in using it due to inconsistencies in condom use, condom use errors, their own or their partners' concurrent sexual partnerships, and rape. Most AGYW hoped that PrEP would be available in youth-friendly sections of health centers for easy access and youth-friendly counselling. They suggested that discrete packaging of PrEP would be needed to ensure user privacy. Concerns about relationship destabilization and accusations of promiscuity were raised as potential barriers to use.ConclusionGeneral interest in PrEP among AGYW was high. Discrete packaging and access to youth-friendly PrEP delivery modalities may facilitate the utilization of PrEP as a prevention strategy among sexually active AGYW. Attention to potential negative reactions from partners and community members to PrEP use will be needed when introducing PrEP to this population.