Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women.

Background: Daily, oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) reduces HIV acquisition for African women. Adherence is key to efficacy and patterns of adherence can be highly variable in real-world settings. Using group-based trajectory modeling (GBTM), we sought to identify distinct patterns of periconception PrEP adherence and evaluate potential baseline predictors of such adherence trajectories. Methods: We conducted a single-arm longitudinal study for women aged 18-35 years living in Durban, South Africa with personal or partner plans for pregnancy with a partner with HIV or of unknown serostatus. Participants were offered safer conception counseling, including daily oral PrEP; women who initiated PrEP were given a bottle with an electronic pillcap that recorded when device opens. Weekly adherence to daily PrEP was modeled using GBTM with a censored normal outcome distribution as a function of weeks since PrEP initiation. The number and functional form of the adherence trajectory groups were primarily selected based on Bayesian information criteria (BIC) and confirmed by mean estimated probabilities of group membership. A multivariable version of the selected model assessed baseline predictors of membership in adherence trajectory groups. Results: Overall mean (95% CI) adherence to PrEP was 63% (60%, 67%). We identified four groups of women with distinct patterns of adherence: (1) high (i.e., ≥6 doses per week) steady adherence throughout follow-up (22% of PrEP initiators); (2) moderate (i.e., 4-5 doses per week), but steady adherence (31%); (3) initially high, but consistently declining adherence (21%); and (4) initially moderate adherence, followed by a rapid decline and subsequent rebound (26%). In multivariable-adjusted analyses, older age was associated with membership in the high, steady adherence group as compared to the group identified with an adherence trajectory of initially high, then decline, and finally a rebound. Conclusions: GBTM is useful for exploring potential heterogeneity in longitudinal patterns of medication adherence. Although a large proportion of women in this study achieved high levels of adherence by electronic pillcap initially, far fewer women maintained these levels consistently. Knowledge of different adherence trajectories could be used to develop targeted strategies for optimizing HIV prevention during periconception.

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.

Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study.

BACKGROUND: Many men with HIV (MWH) want to have children. HIV viral suppression minimizes sexual HIV transmission risks while allowing for conception and optimization of the health of men, their partners, and their infants. OBJECTIVE: This study developed and evaluated the feasibility and acceptability of an intervention to promote serostatus disclosure, antiretroviral therapy (ART) uptake and adherence, and viral suppression among MWH who want to have children in South Africa. METHODS: We developed a safer conception intervention (Sinikithemba Kwabesilisa or We give hope to men) to promote viral suppression via ART uptake and adherence, HIV serostatus disclosure, and other safer conception strategies for MWH in South Africa. Through 3 counseling and 2 booster sessions over 12 weeks, we offered education on safer conception strategies and aided participants in developing a safer conception plan. We recruited MWH (HIV diagnosis known for >1 month), not yet accessing ART or accessing ART for <3 months, in a stable partnership with an HIV-negative or unknown-serostatus woman, and wanting to have a child in the following year. We conducted an open pilot study to evaluate acceptability based on patient participation and exit interviews and feasibility based on recruitment and retention. In-depth exit interviews were conducted with men to explore intervention acceptability. Questionnaires collected at baseline and exit assessed disclosure outcomes; CD4 and HIV-RNA data were used to evaluate preliminary impacts on clinical outcomes of interest. RESULTS: Among 31 eligible men, 16 (52%) enrolled in the study with a median age of 29 (range 27-44) years and a median time-since-diagnosis of 7 months (range 1 month to 9 years). All identified as Black South African, with 56% (9/16) reporting secondary school completion and 44% (7/16) reporting full-time employment. Approximately 44% (7/16) of participants reported an HIV-negative (vs unknown-serostatus) partner. Approximately 88% (14/16) of men completed the 3 primary counseling sessions. In 11 exit interviews, men reported personal satisfaction with session content and structure while also suggesting that they would refer their peers to the program. They also described the perceived effectiveness of the intervention and self-efficacy to benefit. Although significance testing was not conducted, 81% (13/16) of men were taking ART at the exit, and 100% (13/13) of those on ART were virally suppressed at 12 weeks. Of the 16 men, 12 (75%) reported disclosure to pregnancy partners. CONCLUSIONS: These preliminary data suggest that safer conception care is acceptable to men and has the potential to reduce HIV incidence among women and their children while supporting men's health. Approximately half of the men who met the screening eligibility criteria were enrolled. Accordingly, refinement to optimize uptake is needed. Providing safer conception care and peer support at the community level may help reach men. TRIAL REGISTRATION: ClinicalTrials.gov NCT03818984; https://clinicaltrials.gov/ct2/show/NCT03818984. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1007/s10461-017-1719-4.

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.

"It really proves to us that we are still valuable": Qualitative research to inform a safer conception intervention for men living with HIV in South Africa.

OBJECTIVE: Many men living with HIV want to have children. Opportunities to reduce periconception HIV transmission include antiretroviral therapy as prevention, pre-exposure prophylaxis, limiting condomless sex to peak fertility, and sperm processing. Whether men have knowledge of or want to adopt these strategies remains unknown. METHODS: We conducted focus group discussions (FGDs) with men accessing HIV care in South Africa in 2014 to inform a safer conception intervention for men. Eligible men were 25-45 years old, living with HIV, not yet accessing treatment, and wanting to have a child with an HIV-negative or unknown serostatus female partner (referred to as the "desired pregnancy partner"). FGDs explored motivations for having a healthy baby, feasibility of a clinic-based safer conception intervention, and acceptability of safer conception strategies. Data were analyzed using thematic analysis. RESULTS: Twelve participants from three FGDs had a median age of 37 (range 23-45) years, reported a median of 2 (range 1-4) sexual partners, and 1 (range 1-3) desired pregnancy partner(s). A third (N = 4) had disclosed HIV-serostatus to the pregnancy partner. Emergent themes included opportunities for and challenges to engaging men in safer conception services. Opportunities included enthusiasm for a clinic-based safer conception intervention and acceptance of some safer conception strategies. Challenges included poor understanding of safer conception strategies, unfamiliarity with risk reduction [versus "safe" (condoms) and "unsafe" (condomless) sex], mixed acceptability of safer conception strategies, and concerns about disclosing HIV-serostatus to a partner. CONCLUSIONS: Men living with HIV expressed interest in safer conception and willingness to attend clinic programs. Imprecise prevention counseling messages make it difficult for men to conceptualize risk reduction. Effective safer conception programs should embrace clear language, e.g. undetectable = untransmittable (U = U), and support multiple approaches to serostatus disclosure to pregnancy partners.

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.

Developing a Safer Conception Intervention for Men Living with HIV in South Africa.

Within sexual partnerships, men make many decisions about sexual behavior, reproductive goals, and HIV prevention. There are increasing calls to involve men in reproductive health and HIV prevention. This paper describes the process of creating and evaluating the acceptability of a safer conception intervention for men living with HIV who want to have children with partners at risk for acquiring HIV in KwaZulu-Natal, South Africa. Based on formative work conducted with men and women living with HIV, their partners, and providers, we developed an intervention based on principles of cognitive-behavioral therapy to support men in the adoption of HIV risk-reduction behaviors such as HIV-serostatus disclosure and uptake of and adherence to antiretroviral therapy. Structured group discussions were used to explore intervention acceptability and feasibility. Our work demonstrates that men are eager for reproductive health services, but face unique barriers to accessing them.