An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women

Eligibility criteria for enrollment in Group 1 (HIV-positive women): Inclusion Criteria: * Documented pregnancy by urine pregnancy test or physical exam * Documented positive HIV status * Initiated on first-line antiretroviral therapy (ART) within the past 30 days, either for the first time or after treatment interruption of 6 months or longer (if previously started but stopped ART) * Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule * Ability and willingness to provide informed consent Exclusion Criteria: * Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel * Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate Eligibility criteria for enrollment in Group 2 (HIV-negative women): Inclusion Criteria: * Documented pregnancy by urine pregnancy test or physical exam * Documented negative HIV status within the past three months * Identified factor(s) for elevated risk for HIV acquisition, such as known positive or unknown partner HIV status; report of secondary sexual partners over the past 12 months; diagnosis of sexually transmitted infection over the past 12 months; use of post-exposure prophylaxis in the past 12 months; reported use of shared injection material or equipment; and/or unspecified concern about HIV acquisition during pregnancy and breastfeeding * Willingness to initiate and continue HIV pre-exposure prophylaxis (PrEP) over the course of study follow-up * Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule * Ability and willingness to provide informed consent Exclusion Criteria: * Positive HIV test at time of screening * Positive hepatitis B surface antigen test at time of screening * Renal insufficiency, defined as creatinine clearance \<90 mL/min, history of known renal parenchymal disease, or known single kidney at time of screening * Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel * Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate