HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

"Nobody Wants to Have Conversation About HIV." A Thematic Analysis of in-Depth Interviews With Black Adolescent Women and Providers About Strategies for Discussing Sexual Health and HIV Prevention.

BACKGROUND: Black adolescent girls and young women (AGYW) in the US Southeast are disproportionately burdened by HIV. Infrequent assessment of sexual health in clinical encounters may contribute to low preexposure prophylaxis uptake for this population. This study explores Black AGYW and providers' perspectives on engaging in discussions about sexual health, including preexposure prophylaxis. METHODS: In-depth interviews (IDIs) were conducted with Black AGYW aged 14 to 24 years and health care providers (MD, DO, NP, PA) who self-reported caring for Black AGYWs in Alabama. In-depth interviews were grounded in Andersen's Behavioral Model of Health Service Utilization to explore barriers and facilitators to sexual health discussions. After separate analyses, AGYW and provider IDIs were aggregated and reanalyzed using thematic analysis to identify themes related to their views on ways to improve Black AGYW engagement in sexual health discussions while in clinical settings. RESULTS: Twelve Black AGYW and 11 providers completed IDIs. Client median age was 21 years, representing 9 Alabama counties. Providers were predominately non-Hispanic White (82%), female (73%), and physicians (64%). Themes about ways to improve sexual health discussions included the following: (1) improve sexual health education for providers and adolescents, (2) normalize conversations in clinical settings, and (3) engage communities to continue these conversations outside of clinical settings. CONCLUSIONS: Sexual health and HIV prevention discussions with Black AGYW are not occurring. This study is one of the first to identify and highlight Black AGYW and provider-identified shared strategies for improving these discussions. Operationalizing these strategies is crucial to facilitating these discussions.

Sexually Transmitted Infection Prevalence, Partner Notification, and Human Immunodeficiency Virus Risk Perception in a Cohort of Women Completing Sexually Transmitted Infection Screening as Part of a Safer Conception Study.

BACKGROUND: Integrating sexually transmitted infection (STI) and preexposure prophylaxis (PrEP) care may optimize sexual and reproductive health. METHODS: We nested an STI substudy within a human immunodeficiency virus (HIV) prevention cohort (parent study) of 18- to 35-year-old women from South Africa, planning pregnancy with a partner with HIV or of unknown serostatus. Parent-study women completed annual surveys regarding HIV-risk perceptions and were offered oral PrEP. Preexposure prophylaxis initiators completed quarterly plasma tenofovir (TFV) testing. Substudy women completed STI screening at enrollment, 6 months, onset of pregnancy, and in the third trimester via examination, vaginal swabs tested via PCR for Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , Mycoplasma genitalium , and blood tested for Treponema pallidum . Follow-up was 6 months. Women with STIs were treated, offered partner notification (PN) cards, and surveyed regarding PN practices. We describe STI prevalence and incidence, and model factors associated with prevalent infection. Sexually transmitted infection substudy and parent study-only participants were matched on age and number of days on study to assess HIV-risk perception scores between the 2 groups and the proportion with detectable TFV. RESULTS: Among 50 substudy participants, 15 (30%) had prevalent STI. All 13 completing follow-up reported PN. Most did not prefer assisted PN. Mean HIV risk perception scores and proportion with detected plasma TFV were similar across groups. CONCLUSIONS: High STI prevalence supports the importance of laboratory screening to optimize sexual health for women planning pregnancy. Rates of self-reported PN are reassuring; low interest in assisted PN suggests the need for alternative approaches. Enhanced STI care did not affect HIV-risk perception or PrEP adherence, however both were relatively high in this cohort.

Perceptions of Pre-exposure Prophylaxis (PrEP) for HIV prevention among men living with HIV in the context of reproductive goals in South Africa: a qualitative study.

BACKGROUND: Pre-exposure Prophylaxis (PrEP) and Treatment as Prevention (TasP) are effective strategies to prevent HIV transmission within serodifferent couples. However, limited usage of PrEP, knowledge and interest has been amongst the barriers for men, alongside testing and treatment adherence. We explored the perceptions of PreP for HIV prevention with Men living with HIV (MWH) who have reproductive goals, to understand awareness and experiences related to PrEP use in the context of HIV prevention with their partners. METHODS: We undertook a qualitative study with 25 MWH aged 18 to 65 between April and September 2021 in South Africa. Potential participants were screened for eligibility and scheduled to participate in telephonic interviews. Interviews were audio recorded, transcribed, translated and thematically analysed. RESULTS: Themes were organized into opportunities and barriers that men with HIV articulate as important for using PrEP to meet individual, couple, and community reproductive goals. At the individual level, some men were willing to discuss PrEP with their partners to protect their partners and babies from acquiring HIV. Lack of knowledge about PrEP among men was a potential barrier to promoting PrEP among their female partners. At the couple level, PrEP use was seen as a way to strengthen relationships between partners, signifying care, trust, and protection and was seen as a tool to help serodifferent couples meet their reproductive goals safely. At the community level, PrEP was viewed as a tool to promote HIV testing and prevention efforts, especially among men, but participants emphasized the need for more education and awareness. CONCLUSION: Despite PrEP implementation in South Africa, awareness of PrEP among men with HIV in rural areas remains low. Engaging MWH to support their partners in accessing PrEP could be an innovative strategy to promote HIV prevention. Additionally, providing men with comprehensive reproductive health information can empower them to make more informed decisions, adopt safer sexual practices, and challenge societal norms and stigmas around HIV.

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.

BACKGROUND: In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. METHODS AND FINDINGS: We enrolled HIV-negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure ("high" adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as "high." Women who became pregnant were initially exited from the cohort by design; from March 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group. CONCLUSIONS: Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1.

Sexually Transmitted Infection Point-of-Care Testing in Resource-Limited Settings: A Narrative Review Guided by an Implementation Framework.

ABSTRACT: Most sexually transmitted infections (STIs) are acquired in resource-limited settings (RLSs) where laboratory diagnostic access is limited. Advancements in point-of-care testing (POC) technology have the potential to bring STI testing to many RLSs. We define POC as performed near the patient and with results readily available to inform clinical practice. The World Health Organization Special Programme for Research and Training in Tropical Diseases further outlines desirable POC characteristics with the REASSURED criteria.Despite advantages related to immediate test-and-treat care, integrating POC into RLS health care systems can present challenges that preclude reliance on these tests. In 2018, we incorporated molecular near-POC for chlamydia, gonorrhea, and trichomoniasis and SDBioline treponemal immunochromatographic testing confirmed by rapid plasma reagin for syphilis diagnosis at the Mbarara University of Science and Technology Research Laboratory in rural southwestern Uganda. We describe our experiences with STI POC as a case example to guide a narrative review of the field using the Consolidated Framework for Implementation Research as a conceptual framework.Although POC and near-POC are described as easy to use, the challenges of limited person-power, health care processes, limited infrastructure/resources, high costs, and quality control obstacles can impede the impact of these tests. Increased investment in operators, training, and infrastructure, restructuring health care systems to accommodate increased POC access, and optimizing costs are all crucial to the successful implementation of STI POC in RLS. Expanded STI POC in RLS will increase access to accurate diagnoses, appropriate treatment, and engagement in partner notification, treatment, and prevention efforts.

Influences on PrEP Uptake and Adherence Among South African Women During Periconception and Pregnancy: A Qualitative Analysis.

Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet PrEP delivery to women in periconception and pregnancy has lagged. We report qualitative research from a study evaluating PrEP use as part of safer conception care for 330 South African women. Fifty-two semi-structured interviews were conducted with 25 study participants to identify influences on PrEP adherence. Influences were: (1) changing proximity to male partners; (2) COVID-19 lockdown; (3) mobile lifestyle; (4) PrEP-related stigma; (5) disclosure of PrEP use; and (6) pregnancy and motherhood. Data also revealed important contextual information shaping adherence influences for women, including: (a) not living with partners, (b) partners as drivers of pregnancy intention, and (c) feeling at high risk for HIV. Disclosure of PrEP use, addressing stigma, strategies for traveling with pills, and counseling on prevention effective adherence are promising components of PrEP-inclusive HIV prevention interventions for South African women who are pregnant or planning pregnancy.

'I still desire to have a child': a qualitative analysis of intersectional HIV- and childlessness-related stigma in rural southwestern Uganda.

This study explored the intersecting forms of stigma experienced by HIV-serodifferent couples with unmet reproductive goals in rural Uganda. The parent mixed-methods study, which included 131 HIV-exposed women with plans for pregnancy, offered comprehensive HIV prevention counselling and care over a nine-month period. In-depth interviews were conducted with 37 women and seven male partners to explore care experiences and the use of safer conception strategies. This secondary analysis explored how challenges conceiving informed pregnancy plans and HIV prevention behaviours. The following themes were developed (1) partnership conflicts arise from HIV- and infertility-related forms of stigma, contributing to gender-based violence, partnership dissolution and the pursuit of new partners; (2) cultural and gender norms pressure men and women to conceive and maintain partnerships, which is complicated by the stigma directed towards serodifferent couples; (3) frustration with low partner participation in safer conception strategies led to the decreased use of these methods of HIV prevention; (4) health care provider support promotes continued hope of conception and helps overcome stigma. In HIV-affected partnerships, these intersecting forms of stigma may impact HIV prevention. Seeking to fulfil their reproductive needs, partners may increase HIV transmission opportunities as they engage in condomless sex with additional partners and decrease adherence to prevention strategies. Future research programmes should consider the integration of fertility counselling with reproductive and sexual health care.

COVID Community-Engaged Testing in Alabama: Reaching Underserved Rural Populations Through Collaboration.

Rural communities are often underserved by public health testing initiatives in Alabama. As part of the National Institutes of Health's Rapid Acceleration of Diagnostics‒Underserved Populations initiative, the University of Alabama at Birmingham, along with community partners, sought to address this inequity in COVID-19 testing. We describe the participatory assessment, selection, and implementation phases of this project, which administered more than 23 000 COVID-19 tests throughout the state, including nearly 4000 tests among incarcerated populations. (Am J Public Health. 2022;112(10):1399-1403. https://doi.org/10.2105/AJPH.2022.306985).

Understanding the Effect of a Healthcare Provider-Led Family Planning Support Intervention on Contraception use and Pregnancy Desires among Postpartum Women Living with HIV in Southwestern Uganda.

Modern contraceptive prevalence among women living with HIV (WLWH) in Uganda is still low at 45%, and up to a third of women are likely to discontinue the method within the first year of initiation. This increases risks of unplanned pregnancies, perinatal HIV transmission and pregnancy complications. We aim to explore and explain the mechanism of effect of a family planning support intervention investigated in a randomized controlled trial conducted between October 2016 and June 2018 among 320 postpartum WLWH at a referral hospital in Southwestern Uganda that led to improved uptake, decreased contraception discontinuation and lowered pregnancy rates. Thirty WLWH and 10 of their primary sexual partners who participated in this trial were purposively selected and interviewed in the local language; interviews were digitally recorded. Translated transcripts were generated and coded. Coded data were iteratively reviewed and sorted to derive descriptive categories using an inductive content analytic approach. Up to 83% of women wanted to avoid pregnancy within the first year postpartum. Qualitative data showed that contraception uptake and use were influenced by: 1) Participant awareness and understanding of different methods available; 2) Participant perception of offered health services; 3) Healthcare provider (HCP) socio-cultural sensitivity to individual experiences and (mis)conceptions surrounding contraception; 4) Having tactile engagement, follow-up reminders and a reference to prompt action or discussions with partners. Supportive and culturally sensitive HCPs and systems facilitated information sharing leading to increased patient awareness and understanding of the contraceptive methods, and improved health user experience, care engagement, confidence and willingness to take up and continue using modern contraceptive methods.

Sexual and Relationship Benefits of a Safer Conception Intervention Among Men with HIV Who Seek to Have Children with Serodifferent Partners in Uganda.

Many men with HIV (MWH) in Uganda desire children, yet seldom receive reproductive counseling related to HIV care. Because men are under engaged in safer conception programming, they miss opportunities to reap the benefits of these programs. The objective of this sub-analysis was to explore the relationship and intimacy benefits of integrating safer conception counseling and strategies into HIV care, an emergent theme from exit interviews with men who participated in a pilot safer conception program and their partners. Twenty interviews were conducted with MWH who desired a child in the next year with an HIV-uninfected/status unknown female partner, and separate interviews were conducted with female partners (n = 20); of the 40 interviews, 28 were completed by both members of a couple. Interviews explored experiences participating in The Healthy Families program, which offered MWH safer conception counseling and access to specific strategies. Data were analyzed using thematic analysis. Three major subthemes or "pathways" to the relationship and intimacy benefits associated with participation in the program emerged: (1) improved dyadic communication; (2) joint decision-making and power equity in the context of reproduction; and (3) increased sexual and relational intimacy, driven by reduced fear of HIV transmission and relationship dissolution. These data suggest that the intervention not only helped couples realize their reproductive goals; it also improved relationship dynamics and facilitated intimacy, strengthening partnerships and reducing fears of separation. Directly addressing these benefits with MWH and their partners may increase engagement with HIV prevention strategies for conception.

Acceptability of an Intervention to Promote Viral Suppression and Serostatus Disclosure for Men Living with HIV in South Africa: Qualitative Findings.

Men living with HIV (MLWH) often have reproductive goals that can increase HIV-transmission risks to their pregnancy partners. We developed a safer conception intervention for MLWH in South Africa employing cognitive behavioral skills to promote serostatus disclosure, ART uptake, and viral suppression. MLWH were recruited from an HIV clinic near Durban, South Africa, and encouraged to include partners in follow-up visits. Exit in-depth interviews were conducted with eleven men and one female partner. The emerging over-arching theme is that safer conception care mitigates internalized and community-level HIV-stigma among MLWH. Additional related sub-themes include: (1) safer conception care acceptability is high but structural barriers challenge participation; (2) communication skills trainings helped overcome barriers to disclose serostatus; (3) feasibility and perceived effectiveness of strategies informed safer conception method selection. Our findings suggest that offering safer conception care to MLWH is a novel stigma-reducing strategy for motivating HIV prevention and treatment and serostatus disclosure to partners.

Client and Provider Experiences in Uganda Suggest Demand for and Highlight the Importance of Addressing HIV Stigma and Gender Norms Within Safer Conception Care.

Safer conception counseling supports HIV-serodifferent couples to meet reproductive goals while minimizing HIV transmission risk, but has not been integrated into routine HIV care. We piloted a novel safer conception program in an established public-sector HIV clinic in Uganda to inform future implementation. In-depth interviews and counseling observations explored experiences of program clients and healthcare providers to assess program acceptability, appropriateness, and feasibility. Fifteen index clients (8 women, 7 men), 10 pregnancy partners, and 10 providers completed interviews; 15 participants were living with HIV. Ten observations were conducted. We identified four emergent themes: (1) High demand for safer conception services integrated within routine HIV care, (2) Evolving messages of antiretroviral treatment as prevention contribute to confusion about HIV prevention options, (3) Gender and sexual relationship power inequities shape safer conception care, and (4) HIV-related stigma impacts safer conception care uptake. These findings confirm the need for safer conception care and suggest important implementation considerations.

Overcoming Ethical Challenges to Engaging Men Who Have Sex with Women in HIV Research.

Men who have sex with women are understudied in HIV research despite the extent to which they experience HIV-related mortality and contribute to the epidemic among women. During our experience of developing and piloting an HIV prevention intervention for men living with HIV in South Africa, and planning to have a child with an HIV-negative woman, ethical questions were posed regarding implementation of a male-centered intervention that did not require female partner participation. Two overarching ethical issues were the potential for (1) compromising women's reproductive and sexual autonomy and (2) increasing HIV-acquisition risks for the woman because the intervention efficacy was unknown. We describe here how these concerns were addressed to facilitate development of a male-centered HIV-prevention intervention. We hope this process manuscript will support researchers, clinicians, and reviewers to engage men who have sex with women in HIV prevention and care.

"I did not plan that is what hurts": Pregnancy intentions and contraceptive use among pregnant young women in KwaZulu-Natal, South Africa.

Unintended pregnancy impacts many young women in South Africa, and rates of consistent contraceptive use among this population are suboptimal. Limited empirical work has investigated reasons for inconsistency between pregnancy intention and contraceptive use behaviour with data collected during pregnancy. We explored pregnancy intentions and discordance between intentions and contraceptive use prior to conception among young pregnant women in KwaZulu-Natal, South Africa. In-depth qualitative interviews were conducted with 35 women during pregnancy (mean age = 19.3; range = 18-21) in 2011 and 2012. Data were analysed using content analysis. All participants reported unintended pregnancies; almost half were not using contraception near conception. Reasons for not intending to become pregnant spanned personal, social, health, and economic domains. Participants living with HIV (n = 13) expressed specific concerns related to impacts of pregnancy on HIV disease management and fear of transmission of HIV to the infant. Discordance between pregnancy intentions and contraceptive use prior to conception was attributed to personal, social, health and structural domains. Findings indicate a need for interventions that address barriers to contraceptive use in order to minimise unintended pregnancy and support safe, desired pregnancies among young women.

Sexually Transmitted Infection Prevalence Among Women at Risk for HIV Exposure Initiating Safer Conception Care in Rural, Southwestern Uganda.

BACKGROUND: Knowledge of sexually transmitted infection (STI) prevalence and risk factors is important to the development of tenofovir-based preexposure prophylaxis (PrEP) and safer conception programming. We introduced STI screening among women at risk for HIV exposure who were participating in a safer conception study in southwestern Uganda. METHODS: We enrolled 131 HIV-uninfected women, planning for pregnancy with a partner living with HIV or of unknown HIV serostatus (2018-2019). Women were offered comprehensive safer conception counseling, including PrEP. Participants completed interviewer-administered questionnaires detailing sociodemographics and sexual history. We integrated laboratory screening for chlamydia, gonorrhea, trichomoniasis, and syphilis as a substudy to assess STI prevalence. Multivariable logistic regression was used to determine correlates. RESULTS: Ninety-four women completed STI screening (72% of enrolled). Median age was 30 (interquartile range, 26-34) years, and 94% chose PrEP as part of safer conception care. Overall, 24% had STIs: 13% chlamydia, 2% gonorrhea, 6% trichomoniasis, 6% syphilis, and 3% ≥2 STI. Sexually transmitted infection prevalence was associated with younger age (adjusted odds ratio [AOR], 0.87; 95% confidence interval [CI], 0.77-0.99), prior stillbirth (AOR, 5.04; 95% CI, 1.12-22.54), and not feeling vulnerable to HIV (AOR, 16.33; 95% CI, 1.12-237.94). CONCLUSIONS: We describe a 24% curable STI prevalence among women at risk for HIV exposure who were planning for pregnancy. These data highlight the importance of integrating laboratory-based STI screening into safer conception programs to maximize the health of HIV-affected women, children, and families.

Sexual Relationship Power and Periconception HIV-Risk Behavior Among HIV-Infected Men in Serodifferent Relationships.

Gender norms affect HIV risk within serodifferent partnerships. We assessed how the sexual relationship power described by men living with HIV (MLWH) associates with periconception HIV-transmission risk behavior. Quantitative surveys were conducted with 82 MLWH reporting a recent pregnancy with an HIV-negative or unknown-serostatus partner in KwaZulu-Natal, South Africa. Surveys assessed decision-making dominance (DMD) using the Pulerwitz et al. sexual relationship power scale; partnership characteristics; and HIV-risk behaviors. Multivariable logistic regression models evaluated associations between DMD score and HIV-risk behaviors. Higher male decision-making dominance was associated with non-disclosure of HIV-serostatus to pregnancy partner (aRR 2.00, 95% CI 1.52, 2.64), not knowing partner's HIV-serostatus (aRR 1.64, 95% CI 1.27, 2.13), condomless sex since pregnancy (aRR 1.92, 95% CI 1.08, 3.43), and concurrent relationships (aRR 1.50, 95% CI 1.20, 1.88). Efforts to minimize periconception HIV-risk behavior must address gender norms and power inequities.

Provision of family planning vouchers and early initiation of postpartum contraceptive use among women living with HIV in southwestern Uganda: A randomized controlled trial.

BACKGROUND: Unwanted pregnancies remain a burden for women living with HIV (WLWH). Family planning prevents unplanned pregnancies while promoting longer birth intervals, key strategies to eliminate perinatal transmission of HIV and promote maternal and child health. We evaluated the effect of a family planning voucher, inclusive of immediate postpartum counseling, on uptake, early initiation, and continuation of modern contraceptive methods among recently postpartum WLWH delivering at a publicly funded regional referral hospital in rural, southwestern Uganda. METHODS AND FINDINGS: We performed a randomized controlled trial between October, 2016 and June, 2018 at a referral hospital in southwestern Uganda. This interim analysis includes adult WLWH randomized and enrolled equally to receive a family planning voucher or standard of care (control). Enrolled postpartum WLWH completed an interviewer-administered questionnaire at enrollment and 6 months postpartum. Our primary outcome of interest for this analysis is initiation of a modern family planning method within 8 weeks postpartum. Secondary outcomes included family planning initiation at 12, 14, 16, and 20 weeks postpartum, family planning discontinuation and/or change, pregnancy incidence, and mean time without contraception. The trial was registered with clinicaltrials.gov (NCT02964169). At enrollment, half of the women in both the voucher (N = 87, 55%) and control (N = 86, 54%) groups wanted to have a child in 2 years postpartum. Over 80% of referent pregnancies in the voucher (N = 136, 86%) and control (N = 128, 81%) groups were planned. All women were accessing ART. The mean CD4 count was 396 cells/mm3 (SD = 61) for those enrolled in the control group versus 393 cells/mm3 (SD = 64) in the family planning voucher group. By 8 weeks postpartum, family planning was initiated in 144 (91%) participants in the voucher group and 83 (52%) participants in the control group (odds ratio [OR] 9.42; CI 4.67-13.97, P < 0.001). We also found high family planning uptake rates for both groups, with higher rates among the intervention group at 12 weeks (OR 5.66; CI 2.65-12.12, P < 0.001), 14 weeks (OR 2.51; CI 1.31-4.79, P < 0.001), 16 weeks (OR 4.02; CI 1.66-9.77, P = 0.001), and 20 weeks (OR 3.65; CI 1.40-9.47, P = 0.004) postpartum. The average time to family planning initiation was reduced to 5.9 weeks (SD = 2.4) for those in the voucher group compared to 9.3 weeks (SD = 5) in the control (P < 0.001). One pregnancy was recorded in the group receiving standard of care; none were reported in the voucher group. Method mix did not differ by group: injectables were selected by most women (N = 150, 50%), and 52% of this proportion were in the experimental arm, with <10% in each arm selecting condoms, oral contraception, or intrauterine devices (IUDs). Similar proportions of women changed contraceptive methods over the 6-month follow-up in the voucher and control groups (N = 8, 5% versus N = 5, 4%; P = 0.467). More women in the control group discontinued contraception for 1 to 2 weeks (N = 19, 13% versus N = 7, 5%; P = 0.008) or more than 4 weeks (N = 15, 10% versus N = 3, 2%; P = 0.002) compared to those given a family planning voucher. The main limitation of this study is that its findings may not be generalized to settings without improved availability of contraceptives in publicly funded facilities. CONCLUSION: These findings indicate that a well-structured, time-bound family planning voucher program appeared to increase early postpartum contraceptive uptake and continuation in a setting in which users are faced with financial, knowledge, and structural barriers to contraceptive services. Further work should clarify the role of vouchers in empowering WLWH to avoid unintended pregnancies over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT02964169.

Factors Associated with Pregnancy Intentions Amongst Postpartum Women Living with HIV in Rural Southwestern Uganda.

Comprehensive HIV treatment and care makes it safer for women living with HIV (WLWH) to have the children they desire, partly through provision and appropriate use of effective contraception. However, nearly one third of WLWH in-care in a large Ugandan cohort became pregnant within 3 years of initiating ART and half of these incident pregnancies (45%) were unplanned. We therefore describe future pregnancy plans and associated factors among postpartum WLWH in rural southwestern Uganda in order to inform interventions promoting postpartum contraceptive uptake. This analysis includes baseline data collected from adult WLWH enrolled into a randomized controlled trial to evaluate the effect of family planning support versus standard of care at 12 months postpartum in southwestern Uganda. Enrolled postpartum WLWH completed an interviewer-administered questionnaire at enrolment. Among 320 enrolled women, mean age, CD4 count, and duration on ART was 28.9 (standard deviation [SD] 5.8) years, 395 cells/mm3 (SD = 62) and 4.6 years (SD = 3.9), respectively. One-hundred and eighty nine (59%) of women reported either personal (175, 55%) or partner (186, 58%) desire for more children in the next 2 years. Intentions to have more children was strongly associated with partner's desire for more children (AOR = 31.36; P < 0.000), referent pregnancy planned (AOR = 2.69; P = 0.050) and higher household income > 150,000 Shs per month (AOR = 1.37; P = 0.010). Previous use of modern contraception (AOR = 0.07; P = 0.001), increasing age (AOR = 0.34; P = 0.012), having > 2 own children living in a household (AOR = 0.42; P = 0.021) and parity > 2 (AOR = 0.59; P = 0.015) were associated with reduced odds of pregnancy intention. Our findings highlight the role male partners play in influencing pregnancy intentions postpartum and the importance of engaging men in sexual and reproductive health counselling about child spacing for the health of women, children, and families. This should be addressed alongside key individual-level social, demographic, economic and structural factors within which couples can understand risks of unplanned pregnancies and access effective contraceptive methods when they need or want them.

Consensus statement: Supporting Safer Conception and Pregnancy For Men And Women Living with and Affected by HIV.

Safer conception interventions reduce HIV incidence while supporting the reproductive goals of people living with or affected by HIV. We developed a consensus statement to address demand, summarize science, identify information gaps, outline research and policy priorities, and advocate for safer conception services. This statement emerged from a process incorporating consultation from meetings, literature, and key stakeholders. Three co-authors developed an outline which was discussed and modified with co-authors, working group members, and additional clinical, policy, and community experts in safer conception, HIV, and fertility. Co-authors and working group members developed and approved the final manuscript. Consensus across themes of demand, safer conception strategies, and implementation were identified. There is demand for safer conception services. Access is limited by stigma towards PLWH having children and limits to provider knowledge. Efficacy, effectiveness, safety, and acceptability data support a range of safer conception strategies including ART, PrEP, limiting condomless sex to peak fertility, home insemination, male circumcision, STI treatment, couples-based HIV testing, semen processing, and fertility care. Lack of guidelines and training limit implementation. Key outstanding questions within each theme are identified. Consumer demand, scientific data, and global goals to reduce HIV incidence support safer conception service implementation. We recommend that providers offer services to HIV-affected men and women, and program administrators integrate safer conception care into HIV and reproductive health programs. Answers to outstanding questions will refine services but should not hinder steps to empower people to adopt safer conception strategies to meet reproductive goals.