Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Mothers Moving towards Empowerment (MME)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primiparous women aged 18 to 45 diagnosed as HIV+ receiving care through IDCC with Botswana citizenship speak either English or Setswana able to provide informed consent Exclusion Criteria: unable to provide informed consent non-English or Setswana speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mothers Moving towards Empowerment (MME)<br>The MME intervention arm will complete our 8-session intervention, weekly for 60-70 minutes per session. Homework will be assigned each week and reviewed the next session. Certificates will be issued to participants who complete the intervention. Fidelity assessments for each session will be evaluated by local research personnel. | Behavioral: Mothers Moving towards Empowerment (MME)<br>* 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.<br>|
| No Intervention: Treatment As Usual (TAU)<br>Control condition participants will receive Treatment as usual (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 MME intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalized Stigma | Assesses extent HIV stereotypes are applied to the self. 18 items. (scale 0-3). Good reliability & validity | 7 minutes | 
| Anticipated Stigma | Assesses extent people living with HIV/AIDS (PLWHA) anticipate rejection if HIV disclosed. 10 items. (scale 0-3) Good reliability & validity | 4 minutes | 
| Perceived Community Stigma | Assesses extent community members would devalue PLWHA. 20 items (scale: 0-3) Good reliability & validity | 8 minutes | 
| Enacted Stigma | Experienced stigma by PWLHA. 28 items. (scale 0-3). Good reliability & validity | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR Score | Objective: 0-10 as rated by physician (documented at 5 minutes and 10 minutes) | 1minute | 
| Pre-term delivery | Objective: Born prior to 37 weeks or 37 weeks and after (Yes/ No). Check hospital record | 1minute | 
| Mortality | Objective: Mortality (e.g. neonatal, infant mortality) (Yes/No). Check hospital record | 1minute | 
| Birthweight | Objective: Infant weight in grams (low = <2500 g or normal = >2500 g) | 1minute | 
| Vaccinations | Objective: from 0-4 visits; Vaccines given at 0, 2, 3, and 4 months (e.g., BCG's, Hep B) (score: 0-3 months) | 1minute | 
| Infant HIV status | PCR Assay conducted at 6 weeks and reflected in medical record; (Y/N) | 1minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, HIV