Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women
Condition: HIV
Study type: Interventional

Summary: 
      The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a
      stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will
      use empirically tested stigma interventions that have shown efficacy for serious mental
      illness and to adapt these to HIV. Additionally, a novel component of this intervention is
      the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective
      stigma reduction agent for other conditions but has not yet been widely used with HIV.

      The investigators propose to leverage this middle-income context to conduct a Randomized
      Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The
      investigators examine the stigma intervention for outcomes among mothers (including adherence
      to Antiretroviral therapy [ART] and antenatal treatment), and conduct exploratory birth
      outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building
      activities to transfer stigma intervention knowledge will occur throughout the project to
      enable investigators in Botswana to independently develop stigma interventions, thus serving
      as a model for other African countries. Finally, this pilot intervention will provide
      valuable data for future intervention trials to reduce stigma and improve ART adherence.
    

Detailed description: 
      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.
    

Intervention name(s): Mothers Moving towards Empowerment (MME)
Intervention type(s): Behavioral
Intervention description(s): MME integrates 3 components: 1) psychoeducation regarding causes, transmission, and treatment of HIV re how adherence to ART and antenatal care acts to promote health for HIV+ women and PMTCT82,83. We will emphasize ART adherence spanning into PP as a maternal duty to raise a healthy child; 2) challenging stereotypes of HIV+ women, such as promiscuity, that threaten core aspects of being a "good woman" and hinder treatment adherence; 3) coping skills for HIV-related discrimination, i.e., rejection or abandonment by male partners leading to discontinuing treatment adherence and impacts on raising children.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To account for expected drop out (~10%), ~220 participants will be recruited, resulting in MME and TAU groups of ~100 with complete data by the 56th week following the beginning of pregnancy. For the MME arm, we 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: HIV; Stigma