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

Inclusion Criteria

• •Eligibility criteria for enrollment in Group 1 (HIV-positive women):
• •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
• •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