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Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa.

ABSTRACT: INTRODUCTION:Women who choose to conceive a baby with a partner living with HIV or a partner whose HIV serostatus is unknown in HIV-endemic settings need prevention strategies to mitigate HIV acquisition during conception and pregnancy. METHODS AND ANALYSIS:We are conducting a single-arm longitudinal study offering oral tenofovirdisoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South Africa. PrEP is offered as part of woman-centred safer conception programme that promotes couples-based HIV counselling and testing, antiretroviral therapy for partners who are HIV-infected, treatment for sexually transmitted infections and safer conception strategies, such as limiting condomless sex to peak fertility. We enrol HIV-uninfected women who are not currently pregnant, in a stable relationship (?6 months) with a partner living with HIV or of unknown serostatus, and personal or partner plans for pregnancy in the next 12 months. We follow enrolled women for 12 months. Women who become pregnant are followed through pregnancy outcome, independent of their decisions regarding PrEP use. The primary objective of the study is to evaluate the uptake of and adherence to PrEP during the periconception period and pregnancy. Secondary outcomes include the uptake of other safer conception strategies. We also measure clinical outcomes including HIV seroconversion rates and pregnancy and infant outcomes. Finally, we will explore conduct and evaluate qualitative interviews in 25 participants to further inform our conceptual framework for periconception PrEP uptake and adherence among HIV-exposed women in South Africa. ETHICS AND DISSEMINATION:The protocol has been approved by the Human Research Ethics Committee at the University of the Witwatersrand (Johannesburg, South Africa) and the Institutional Review Board of Partners Healthcare (Boston, Massachusetts, USA). Study findings will be made available to interested participants. Results will be presented to local health officials and stakeholders at meetings. Investigators will share the results at meetings and in manuscripts. De-identified quantitative data will be made available. TRIAL REGISTRATION NUMBER:The protocol is registered with the South African Health Products Regulatory Agency (SAHPRA, formerly known as the Medicine Controls Council, MCC#20170131) and ClinicalTrials.gov (NCT03194308); Pre-results.

SUBMITTER: Matthews LT

PROVIDER: S-EPMC6661571 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa.

Matthews Lynn T LT Jaggernath Manjeetha M Kriel Yolandie Y Smith Patricia M PM O'Neil Kasey K Haberer Jessica E JE Hendrix Craig C Baeten Jared M JM Ware Norma C NC Wirth Kathleen K Psaros Christina C Bangsberg David R DR Smit Jennifer A JA

BMJ open 20190726 7

<h4>Introduction</h4>Women who choose to conceive a baby with a partner living with HIV or a partner whose HIV serostatus is unknown in HIV-endemic settings need prevention strategies to mitigate HIV acquisition during conception and pregnancy.<h4>Methods and analysis</h4>We are conducting a single-arm longitudinal study offering oral tenofovirdisoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South ...[more]

PMID: 31350241

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Project description:BackgroundSafer conception strategies empower individuals trying to conceive to minimise HIV transmission risk to partners and potential children; however, effectiveness data are scarce. We aimed to assess adoption of safer conception methods and HIV and pregnancy outcomes from Sakh'umndeni, a novel safer conception service in South Africa.MethodsIn this prospective cohort study, the Sakh'umndeni clinical cohort at Witkoppen Cinic in Johannesburg (South Africa) enrolled adults aged at least 18 years who were trying to conceive and in relationships with an HIV-positive partner. Couples who were pregnant at enrolment or had been previously diagnosed as infertile were excluded. Participants received safer conception care by a nurse, including antiretroviral therapy (ART) for HIV-positive partners, pre-exposure prophylaxis (PrEP) for HIV-negative partners, counselling around timed condomless sex, or syringes for self-insemination. Primary outcomes were pregnancy incidence and HIV transmission to partners and infants. We estimated time to first pregnancy using Kaplan-Meier curves; pregnancy and HIV incidence were estimated as events per person-years of risk.FindingsBetween July 16, 2013, and April 5, 2017, 526 individuals (334 women and 192 men) from 334 partnerships enrolled. 162 (48%) of 334 couples were serodifferent, 149 (45%) were HIV-positive seroconcordant, and 23 (7%) were an HIV-positive woman and an unknown status male partner. At enrolment, 176 (61%) of 287 HIV-positive women and 60 (46%) of 131 HIV-positive men were virally suppressed (<50 copies per mL). Among the safer conception strategies, ART was initiated by 73 (91%) of 80 HIV-positive participants not on ART and PrEP was initiated by 28 (28%) of 101 HIV-negative participants. 2719 follow-up visits were completed, and 99 pregnancies were observed in 89 women. Pregnancy incidence was 41·2 per 100 person-years (95% CI 33·4-50·7); 25 (28%) of 89 pregnancies with a known outcome were miscarried or terminated because of risk to the mother. Pregnancy incidence was 79·0 per 100 person-years (95% CI 49·8-125·4) among HIV-negative women and 36·7 per 100 person-years (29·1-46·3) among HIV-positive women. At the time of pregnancy, viral suppression among women was high (68 [87%] of 78 women had viral loads of <50 copies per mL and 77 [99%] had viral loads of <1000 copies per mL). No horizontal or vertical HIV transmission events were observed.InterpretationSafer conception strategies empowered couples to safely conceive. Pregnancy incidence among service users was high. Integration of safer conception counselling could promote HIV prevention and linkage to care.FundingUS Agency for International Development; UJMT Consortium/Fogarty International Center, US National Institutes of Health (NIH); and Johns Hopkins University Center for AIDS Research (NIH).

Project description:BackgroundSubfertility among couples affected by HIV has an impact on the well-being of couples who desire to have children and may prolong HIV exposure. Subfertility in the antiretroviral therapy era and its determinants have not yet been well characterized.ObjectiveThe objective of the study was to investigate the burden and determinants of subfertility among HIV-affected couples seeking safer conception services in South Africa.Study designNonpregnant women and male partners in HIV seroconcordant or HIV discordant relationships desiring a child were enrolled in the Sakh'umndeni safer conception cohort at Witkoppen Clinic in Johannesburg between July 2013 and April 2017. Clients were followed up prospectively through pregnancy (if they conceived) or until 6 months of attempted conception, after which they were referred for infertility services. Subfertility was defined as not having conceived within 6 months of attempted conception. Robust Poisson regression was used to assess the association between baseline characteristics and subfertility outcomes; inverse probability weighting was used to account for missing data from women lost to safer conception care before 6 months of attempted conception.ResultsAmong 334 couples enrolled, 65% experienced subfertility (inverse probability weighting weighted, 95% confidence interval, 0.59-0.73), of which 33% were primary subfertility and 67% secondary subfertility. Compared with HIV-negative women, HIV-positive women not on antiretroviral therapy had a 2-fold increased risk of subfertility (weighted and adjusted risk ratio, 2.00; 95% confidence interval, 1.19-3.34). Infertility risk was attenuated in women on antiretroviral therapy but remained elevated, even after ≥2 years on antiretroviral therapy (weighted and adjusted risk ratio, 1.63; 95% confidence interval, 0.98-2.69). Other factors associated with subfertility were female age (weighted and adjusted risk ratio, 1.03, 95% confidence interval, 1.01-1.05 per year), male HIV-positive status (weighted and adjusted risk ratio, 1.31; 95% confidence interval, 1.02-1.68), male smoking (weighted and adjusted risk ratio, 1.29; 95% confidence interval, 1.05-1.60), and trying to conceive for ≥1 year (weighted and adjusted risk ratio, 1.38; 95% confidence interval, 1.13-1.68).ConclusionTwo in 3 HIV-affected couples experienced subfertility. HIV-positive women were at increased risk of subfertility, even when on antiretroviral therapy. Both male and female HIV status were associated with subfertility. Subfertility is an underrecognized reproductive health problem in resource-limited settings and may contribute to prolonged HIV exposure and transmission within couples. Low-cost approaches for screening and treating subfertility in this population are needed.

Project description:IntroductionHIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.MethodsThe 3Ps for Prevention Study was a 12-month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention-to-treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.ResultsMedian age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV-DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty-five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV-DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.ConclusionsAmong South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12-month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer-acting PrEP formulations are needed.

Dataset Information

Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa.

Publications

Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa.

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