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Introduction: Couple-based behavioral interventions (CBIs) have been associated with improved HIV virological outcomes for pregnant women and their male partners living with HIV in observational settings, but have never been tested in a randomized controlled trial (RCT)., Setting: Bwaila District Hospital Antenatal clinic (Lilongwe, Malawi)., Methods: An RCT was conducted among 500 pregnant women living with HIV (index clients) randomized 1:1 to the standard of care (SOC) or CBI and followed for one year. The CBI offered an initial session for index clients, HIV assisted partner notification, two enhanced couple counseling and testing sessions, illustrated materials, and antiretroviral therapy pick-up for either couple member at the antenatal clinic. At 12 months, viral load among index clients and male partners with HIV was measured. Risk differences (RD) and 95% confidence intervals (CIs) compared viral suppression (<1000 copies/ml) between arms., Results: Mean index client age was 26.6 years; most were married or cohabiting (93.3%). Index client viral suppression was 6.5% higher in the CBI arm (88.0%) than in the SOC arm (81.6%). Male partner viral suppression was 16.2% higher in the CBI arm (73.6%) than the SOC arm (57.4%). Overall couple viral suppression was 7.8% higher (CI: 0.5% to 15.1%, p=0.04) in the CBI arm (84%) than in the SOC arm (76.0%). Social harms were rare (3.6%) and comparable between arms (p=0.8)., Conclusion: This CBI had a positive impact on couple viral suppression. Scaling this CBI to antenatal clients with HIV and their male partners could improve HIV outcomes among expecting families., Competing Interests: Conflict of interest and source of Funding: The study was supported by funding from the National Institutes of Health (R00 MH104154, R01 MH124526) with support to investigators from The UNC Center for AIDS Research. N. McGrath is a recipient of an NIHR Global Health Research Professorship award (Ref: RP-2017-08-ST2-008). We report no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV incidence in pregnant and breastfeeding women, but adherence is essential., Methods: We conducted a pilot randomized trial to evaluate an intervention package to enhance antenatal and postnatal PrEP use in Lilongwe, Malawi. The intervention was based on patient-centered counseling adapted from previous PrEP studies, with the option of a participant-selected adherence supporter. Participants were locally eligible for PrEP and randomized 1:1 to intervention or standard counseling (ie, control) and followed for 6 months. Participants received the intervention package or standard counseling at enrollment, 1, 3, and 6 months. Adherence was measured through plasma and intracellular tenofovir concentrations and scored using a published algorithm. Our primary outcome was retention in care with concentrations consistent with 4-7 doses/week., Results: From June to November 2020, we enrolled 200 pregnant women with the median gestational age of 26 (interquartile range: 19-33) weeks. Study retention was high at 3 months (89.5%) and 6 months (85.5%). By contrast, across the 2 time points, 32.8% of participants retained in the study had adherence scores consistent with 2-5 doses/week while 10.3% had scores consistent with daily dosing. For the composite primary end point, no substantial differences were observed between the intervention and control groups at 3 months (28.3% vs. 29.0%, probability difference: -0.7%, 95% confidence interval: -13.3%, 11.8%) or at 6 months (22.0% vs. 26.3%, probability difference: -4.3%, 95% confidence interval: -16.1%, 7.6%)., Conclusions: In this randomized trial of PrEP adherence support, retention was high, but less than one-third of participants had pharmacologically confirmed adherence of ≥4 doses/week. Future research should focus on antenatal and postnatal HIV prevention needs and their alignment across the PrEP continuum, including uptake, persistence, and adherence., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

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.