Randomized Controlled Trial to Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women in Botswana

To be completed by University of Botswana Research team:

The investigators will sample from the Dept. of Obstetrics and Gynecology (OB/GYN) at Princess Marina Hospital IDCC. Newly-diagnosed pregnant HIV+ women are referred to OB care at Ministry of Health (MOH) antenatal clinics and receive HIV care at the IDCC for continued ART. To account for expected drop out (~10%), ~220 participants will be recruited. All participants will be randomized to receive MME (the HIV-stigma intervention) or TAU (treatment as usual) from week 28-36 of their pregnancy. The investigators will initiate MME in the antenatal period because the cultural practice of botsetsi (below) could impede implementation post-partum. All participants will have PMTCT by initiation of ART before week 32. Adherence to ART, antenatal and PP care, and viral load testing will be tracked from week 28 of pregnancy to 16 weeks PP (~week 56 for full-term babies).

Procedures. To account for expected drop out (~10%), ~220 participants will be recruited, resulting in MME and TAU groups of ~100 with complete data at week 56. For the MME (intervention) arm, the investigators will enroll 9-10 women per group on a rolling basis to comprise ~12 intervention groups total; ~1 MME group will be initiated per month.

Intervention & Assessment Procedures. One advantage of our study is that, whenever possible, the investigators augment self-report measures with objective measures from medical records (i.e., for infants, birth-weights, APGAR scores at birth; for antenatal treatment, an Antenatal/delivery record tracking antenatal visits that is filled out by doctors; for ART, CD4 count and Viral load data from the integrated patient management system). Fidelity assessments for each session will be evaluated by Ho-Foster. Control Description: Control condition participants will receive TAU, including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the intervention group.

Follow-up Assessment (Months 18-22): Mothers' Postpartum (PP) adherence (56 weeks) serves as a key outcome. The investigators examine a set of exploratory, infant birth outcomes that may result from improved antenatal care and ART adherence. The investigators use an "Under 5 (years old) card" that is filled out by a doctor to track infant's developmental outcomes which is carried by the mother. Child outcomes include: APGAR score, preterm delivery, mortality (at <16 weeks), birthweight, vaccination record, and mother-to-child-transmission of HIV (MTCT). The investigators will call each participant at 4 months' time and ask to meet in person to review their "Under 5 card" to record infant outcomes at both: a) time of birth; b) 16 weeks PP.