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South African women experience high levels of alcohol use and HIV infection during the perinatal period. Oral pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV risk. We examined associations between alcohol use and PrEP use during pregnancy and postpartum.PrEP-PP is a prospective observational cohort of 1200 HIV-negative pregnant women enrolled at first antenatal care visit and followed through 12 months postpartum in Cape Town, South Africa. The analytic sample comprised pregnant women who initiated PrEP at baseline and were not censored from study follow-up prior to 3 month follow-up. We examined associations between any or hazardous alcohol use (AUDIT-C score ≥3) in the year prior to pregnancy and PrEP continuation and adherence during pregnancy (self-report of missing2 doses in past 7 days, and biomarker-confirmed with tenofovir diphosphate in dried blood spots).Of 943 women on PrEP (median age 26 years), 50% reported alcohol use prior to pregnancy and 33% reported hazardous use. At 3 month follow-up, 58% of women were still using PrEP; 41% reported recent adherence and 23% were biomarker-confirmed adherent. In multivariable models, hazardous alcohol use was associated with increased odds of continuing PrEP (aOR=1.54, 95% CI: 1.16-2.06), self-reported PrEP adherence (aOR=1.41, 95% CI: 1.07-1.87), and biomarker- confirmed PrEP adherence (aOR=1.35 95% CI: 0.98, 1.87). Associations were similar in models of any alcohol use and PrEP continuation/adherence.Pregnant and postpartum women who reported recent alcohol use had increased odds of continuing to take PrEP, indicating that higher risk women may continue on oral PrEP.

IntroductionLong-acting pre-exposure prophylaxis (PrEP) options could overcome some barriers to oral PrEP persistence during pregnancy and postpartum. We evaluated long-acting PrEP preferences among oral PrEP-experienced pregnant and postpartum women in South Africa and Kenya, two countries with high coverage of oral PrEP and with pending regulatory approvals for long-acting injectable cabotegravir and the dapivirine vaginal ring (approved in South Africa, under review in Kenya).MethodsFrom September 2021 to February 2022, we surveyed pregnant and postpartum women enrolled in oral PrEP studies in South Africa and Kenya. We evaluated oral PrEP attitudes and preferences for existing and future long-acting PrEP methods.ResultsWe surveyed 190 women in South Africa (67% postpartum; median age 27 years [IQR 22-32]) and 204 women in Kenya (79% postpartum; median age 29 years [IQR 25-33]). 75% of participants reported oral PrEP use within the last 30 days. Overall, 49% of participants reported negative oral PrEP attributes, including side effects (21% South Africa, 30% Kenya) and pill burden (20% South Africa, 25% Kenya). Preferred PrEP attributes included long-acting method, effectiveness, safety while pregnant and breastfeeding, and free medication. Most participants (75%, South Africa and Kenya) preferred a potential long-acting injectable over oral PrEP, most frequently for longer duration of effectiveness in South Africa (87% South Africa, 42% Kenya) versus discretion in Kenya (5% South Africa, 49% Kenya). 87% of participants preferred oral PrEP over a potential long-acting vaginal ring, mostly due to concern about possible discomfort with vaginal insertion (82% South Africa, 48% Kenya). Significant predictors of long-acting PrEP preference included past use of injectable contraceptive (aOR 2.48, 95% CI: 1.34, 4.57), disliking at least one oral PrEP attribute (aOR 1.72, 95% CI: 1.05, 2.80), and preferring infrequent PrEP use (aOR 1.58, 95% CI: 0.94, 2.65).ConclusionsOral PrEP-experienced pregnant and postpartum women expressed a theoretical preference for long-acting injectable PrEP over other modalities, demonstrating potential acceptability among a key population who must be at the forefront of injectable PrEP rollout. Reasons for PrEP preferences differed by country, emphasizing the importance of increasing context-specific options and choice of PrEP modalities for pregnant and postpartum women.

Background In South Africa, at least 7.5 million people (age ≥15 years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15 years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known. Methods We purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July–September 2020. We restricted our analysis to pregnant AGYW (age: 16–25 years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25 days in the past 30 days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5 days in the last 30 days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo-v.1.5. Results We interviewed 18 AGYW (mean age = 22 years), at a mean of 14 weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners’ (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation. Conclusions PrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting.

Background Oral daily preexposure prophylaxis (PrEP) using emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is recommended as standard of care for prevention in individuals at high risk for HIV infection, including pregnant and postpartum cisgender women. FTC/TDF is also active against hepatitis B virus (HBV); however, concern has been raised that providing PrEP to individuals infected with HBV could lead to hepatitis flares and liver injury, especially in the setting of suboptimal PrEP use. Methods We conducted a cross-sectional analysis of baseline data from the PrEP in pregnant and postpartum women (PrEP-PP) cohort study from February 2020–March 2022 in one antenatal care clinic in Cape Town, South Africa (SA) to evaluate: (1) the field performance of a point of care test (POCT) (Determine II, Abbott Inc., Japan) for diagnosis of hepatitis B surface antigen (HBsAg) in a maternity setting, (2) the prevalence of HBV in a cohort of pregnant women not living with HIV. Results We enrolled 1194 HIV sero-negative pregnant women at their first antenatal visit. Median age was 26 years (IQR = 22–31 years); 52% were born before 1995 (before universal HBV vaccination had started in South Africa). Median gestational age was 22 weeks (IQR = 16–30 weeks). There were 8 POCT and laboratory confirmed HBV cases among 1194 women. The overall prevalence of 0.67% (95% CI = 0.34–1.32%). In women born before 1995, 8 of 622 women were diagnosed with HBsAg; the prevalence was 1.29% (95% CI = 0.65–2.52%), and in women born in 1995 or after (n = 572); the prevalence was 0% (95% CI = 0.0–0.67%). We confirmed the test results in 99.8% of the rapid HBsAg (Determine II). Sensitivity was 100% (95% CI = 68–100%). Specificity was 100% (95% CI = 99.67–100%). Conclusion The prevalence of HBV was very low in pregnant women not living with HIV and was only in women born before the HBV vaccine was included in the Expanded Program of Immunization. The Determine II POCT HBsAg showed excellent performance against the laboratory assay. HBV screening should not be a barrier to starting PrEP in the context of high HIV risk communities.

IntroductionPre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women's risk of HIV in pregnancy and postpartum. Effective PrEP protection requires daily PrEP adherence, but little is known about maternal PrEP continuation and factors that influence PrEP use.MethodsThe PrEP in pregnancy and postpartum (PrEP-PP) study enrolled consenting pregnant, HIV-negative women at first antenatal care (ANC) visit with follow-up through 12 months postpartum. Eligible and consenting women and girls ≥16 years received HIV prevention counselling and were offered PrEP. Interviewers collected socio-demographic and behavioural data from participants at each visit. We analysed the proportion of women who initiated PrEP and the proportion who continued PrEP after 3 months with associated correlates by estimating the prevalence ratio adjusting for a priori confounders.ResultsBetween August 2019 and October 2021, we enrolled 1201 pregnant women (median gestation 21 weeks; age 26 years); 84% of women initiated PrEP at their first ANC visit (n = 1014); 55% were married or cohabiting. Overall, 66% of women on PrEP returned for a repeat prescription at 1 month; 58% returned at 3 months (n = 493 of 844). Almost one-half of women on PrEP reported a side effect at 1 month, mostly nausea/vomiting. Women on PrEP in the first and second trimesters had higher odds of reporting side effects (aOR 2.61; 95% CI 1.17-5.84) versus postpartum women. Women who reported side effects continued with PrEP less than those who did not report side effects (aPR = 0.87; 95% CI 0.77-0.97). Women with ≥1 previous pregnancy (aPR = 0.76; 95% CI 0.57-1.01) or were postpartum (aPR 0.85; 95% CI 0.75-0.97) were less likely to continue PrEP compared to women who were primigravid or pregnant. Women who reported having an HIV+ partner (aPR = 1.45; 95% CI 1.13-1.85) or high HIV risk perception (aPR = 1.20, 95% CI = 1.01-1.41) were more likely to continue on PrEP than those who had HIV-negative partners or low risk perception.ConclusionsPrEP initiation and early continuation were high in this setting, compared to other studies in women. Being postpartum and experiencing side effects were associated with lower PrEP continuation, presenting opportunities for counselling on early transient side effects. Interventions for postpartum women on PrEP are needed.

Background Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. Human immunodeficiency virus self-testing (HIVST) for male partners combined with biofeedback counseling through real-time adherence measures may improve PrEP use among postpartum women. Methods Between August 2020 and April 2021, we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counseling after urine tenofovir test) or to standard of care ([SOC] facility-based human immunodeficiency virus [HIV] tests and routine counseling without biofeedback). The outcomes of interest were PrEP adherence in the past 48–72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomization. Secondary outcomes included the proportion of partners who tested for HIV and the discrepancy between self-reported PrEP adherence and urine tenofovir result. Results We enrolled 106 women (median age = 26 years). At enrollment, 72% of women reported missing 5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR = 0.33; 95% CI = 0.17–0.67; P = .03). No social or clinical adverse events were reported in the intervention arm. Conclusions The HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population., We evaluated if HIV self-testing for male partners with counseling following urine tenofovir testing improved PrEP adherence in a randomized trial of n = 106 postpartum women taking PrEP. Recent PrEP adherence per urine tenofovir was 1.8-times higher in the intervention compared to control (RR = 1.83;95% CI = 1.19–2.82).

This study examines baseline associations between alcohol use and HIV sexual risk among a cohort of HIV-uninfected pregnant women (n = 1201) residing in a high HIV burdened community in Cape Town,South Africa. Alcohol use was measured using a modified version of the Alcohol Use Disorder Identification Test (AUDIT). HIV sexual risk was measured through a composite variable of four risk factors: diagnosis with a STI, self-report of > 1 recent sex partners, partner HIV serostatus (unknown or HIV+) and condomless sex at last sex. Any past year alcohol use prior to pregnancy was reported by half of participants (50%); 6.0% reported alcohol use during pregnancy. Alcohol use prior to pregnancy was associated with increased odds of being at high risk of HIV (aOR = 1.33, 95% CI 1.05-1.68, for 2 risks and aOR = 1.47, 95% CI 0.95-2.27 for 3 risks). In addition to reducing alcohol use, several other strategies to address HIV sexual risk were identified. Evidence-based interventions to address alcohol use and other HIV sexual risk behaviors during pregnancy in South Africa are desperately needed. Qualitative work exploring individual and community level drivers of alcohol use among pregnant and breastfeeding women in this setting could support development of a culturally tailored intervention to address these issues in this population.

BackgroundPre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. HIV self-testing (HIVST) for partners combined with biofeedback counselling through real-time adherence measures may improve daily PrEP use among postpartum women.MethodsBetween August 2020 and April 2021 we conducted a pilot study in one primary care clinic in Cape Town, South Africa. We randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counselling following urine tenofovir test) or to standard of care (facility-based HIV tests and routine counselling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomisation. Secondary outcomes included proportion of partners who tested for HIV and discrepancy between self-reported PrEP adherence and urine tenofovir result.FindingsWe enrolled 106 women (median age=26 years; median months postpartum=2). Almost half of women reported having sex since giving birth (48%); 76% of those reported condomless sex at last sex. At enrolment most women (72%) reported missing InterpretationIn this pilot study, HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population.FundingOur study is funded by Fogarty International Center (K01TW011187) with additional support from NIMH (R01MH116771). Trial registration:Clinicaltrials.gov(NCT04897737). Funders had no role in data collection or analysis.

IntroductionOral pre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women’s risk of HIV in pregnancy and postpartum. Effective PrEP requires daily PrEP adherence, but little is known about maternal PrEP continuation and risk factors that influence optimal PrEP use.MethodsThe PrEP in pregnancy and postpartum (PrEP-PP) study is an ongoing cohort study that enrolled consenting pregnant, HIV-uninfected women at first antenatal care (ANC) visit, followed through 12-months postpartum. HIV-uninfected women and girls ≥16-years who were eligible for the study received HIV prevention counseling and were offered PrEP. Interviewers collected socio-demographic, behavioral data from participants at each visit. We analyzed the proportion of women who initiated PrEP and the proportion who continued on PrEP after 3-months with associated correlates, including side effects whilst on PrEP, by estimating the prevalence ratio (95% CI) adjusting for a priori confounders.ResultsBetween Aug’19 and Feb’21, we enrolled 891 pregnant women (median gestation=21wks; age=26yrs). Following PrEP counseling, 90% of women initiated PrEP at their first ANC visit (n=801); 60% were married or cohabiting. Three-quarters of women on PrEP returned for a repeat prescription at 1-month; 62% returned at 3-months. One-third of women on PrEP reported a side effect, mostly nausea/vomiting, dizziness, and headache. Women on PrEP in the 1st or 2nd trimester had higher odds of reporting side effects (aOR=2.61; 95%CI=1.17-5.84) vs. postpartum women. Women who reported side effects continued with PrEP less than those who did not report side effects (aPR=0.88; 95% CI=0.78-0.99) adjusting for covariates. Women who had ≥1 previous pregnancy (aPR=0.76;95%CI=0.59-1.00) or were postpartum (aPR=0.86;95%CI=0.75-0.99) continued less than women who were primigravid or pregnant. Women who reported having an HIV+ partner (aPR= 1.70;95% CI=1.55-1.86) or unknown partner serostatus (aPR=1.14;95%CI=1.01-1.29) were more likely to continue on PrEP than those who had HIV-negative partners.ConclusionPrEP initiation and early continuation were high in ANC in this setting. Being postpartum and experiencing side effects were associated with lower PrEP continuation, presenting an opportunity for improved clinical management and counseling during pregnancy of nausea/vomiting to address early, transient side effects. Interventions for postpartum women on PrEP are urgently needed.Clinical Trial NumberNCT03826199

Pregnant women in sub-Saharan Africa are at high risk of HIV acquisition and require effective methods to prevent HIV. In a cohort of pregnant women offered Pre-exposure prophylaxis (PrEP), we evaluate the relationship between internalized and anticipated stigma and PrEP initiation at first antenatal visit, 3-month continuation and adherence using multivariable logistic regression. High internalized and anticipated PrEP stigma are associated with lower PrEP care initiation at first antenatal visit (aOR internalized stigma = 0.06; 95% CI = 0.03–0.11 and aOR anticipated stigma = 0.55; 95% CI = 0.31–1.00) compared to women with low reported stigma, after controlling for covariates. Women whose partners have not been tested for HIV or whose serostatus remains unknown have 1.6-times odds of PrEP retention at 3-months compared to women whose partners have been tested (aOR = 1.60; 95% CI = 1.02–2.52) after adjusting for covariates. PrEP counseling and maternal PrEP interventions must consider individual- and relational-level interventions to overcome anticipated PrEP stigma and other barriers to PrEP initiation and adherence. Supplementary Information The online version contains supplementary material available at 10.1007/s10461-021-03374-x.