A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Mashia

• Registration Number: NCT03600142
• Lead Sponsor: University of Utah

Brief Summary

This study will pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to antenatal care in Tanzania and male partners who accompany them. The intervention will include: 1) a video and brief counseling that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for individuals who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement. The primary intervention outcome is engagement in PMTCT care among women who are HIV infected. The investigators will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of participants, including individuals who are already established on ART and indiviudals who are HIV uninfected.

Detailed Description

HIV-related stigma has been identified as a significant reason for loss to follow up in prevention of mother-to-child transmission of HIV (PMTCT) programs. Antenatal care (ANC) provides a unique and important entry point to address HIV stigma. Stigma-based counseling during the first ANC visit can promote readiness to initiate or sustain treatment among those who are HIV infected, and can address stigmatizing attitudes and behaviors among those who are uninfected. We are proposing to pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women and their partners presenting to ANC in Tanzania. The intervention will include: 1) a video and brief counseling for women and their partners (if present) that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for women who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement, with the opportunity for male partners to attend the first follow-up counseling session after testing. The primary intervention outcome is engagement in PMTCT care among women who are HIV infected. As a secondary outcome we will also look at linkage to HIV care among men who are HIV infected. We will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of people, including those who are already established on ART and those who are HIV uninfected. The intervention content is based on principles of cognitive-behavioral therapy (addressing automatic negative thoughts about the self, future and the world) to address and mitigate multiple forms of HIV stigma (internalized, anticipated and enacted). We will conduct a pilot RCT of the intervention, enrolling all women who attend a first ANC appointment at two clinics in the Moshi district. If women come to the ANC visit with a male partner, the partner will be invited to enroll as well. Maisha will be compared to the standard of care HIV counseling. In addition to a baseline assessment, all participants who are identified as HIV-infected and their partners will get a follow-up assessment three months after enrollment. A subset of participants who are identified as HIV-uninfected but who report high levels of HIV stigmatizing attitudes at baseline will also receive a follow-up assessment three months after enrollment. Measures will include health outcomes (care engagement, adherence, depression), stigma outcomes, and HIV disclosure. Quality assurance data will be collected and the feasibility and acceptability of the intervention and RCT will be described. Statistical analysis will examine differences between conditions in health outcomes and stigma measures, stratified by HIV status. We hypothesize that 1) among HIV infected individuals, individuals receiving the Maisha intervention will report better engagement in PMTCT care/linkage to HIV care and lower levels of internalized HIV stigma, as compared to individuals receiving the standard of care, and 2) among HIV uninfected individuals, individuals receiving the pre-test video and counseling will report lower levels of stigmatizing attitudes when compared with the control group.

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Study Start: 2019-04-08
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Results First Submitted: 2021-06-24
• Results First Submitted QC: 2021-08-23
• Results First Posted: 2021-09-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1539

Inclusion Criteria

• 18 years of age or older
• If female: Pregnant and attending first antenatal care (ANC) appointment for the current pregnancy at one of the two study sites
• If male: Accompanying an enrolled woman to her first ANC appointment.

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Exclusion Criteria

• Impaired mental status
• Does not speak Swahili

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SoC + stigma counseling (Maisha)	Mashia	Participants randomized to the intervention condition will receive the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tests positive for HIV, two counseling sessions. If a male partner is present with the women, he may also be enrolled and participate in the first two counseling sessions together with the woman.

Primary Outcome Measures

Name	Time	Method
HIV Care Engagement (Female HIV-infected Participants Only)	Post-assessment (3 months after enrollment)	For HIV-infected female participants, retention in care will be assessed via medical record review, with retention defined as having no more than a 60 day gap between PMTCT visits at the study clinic, or having record of an official transfer to another clinic.
Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)	Post-assessment (3 months after enrollment)	Self-report, measured by a modified version of personal and attributed stigma scales (Visser, Kershaw, Makin, \& Forsyth, 2008); Scoring: 6 items. Item scores range from 0-3 (Strongly Disagree to Strongly Agree). Item responses are totaled for a summary score. Total scores range 0-18, with higher scores indicating greater stigma.

Trial Locations

Locations (1)

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania