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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Mashia

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 Type: Interventional
• Enrollment (Actual): 1539
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Moshi, Tanzania
    • Kilimanjaro Christian Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

• Impaired mental status
• Does not speak Swahili

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of Care (SoC); Participants randomized to the control condition will receive the standard HIV counseling protocol in the clinic, which is administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tests positive for HIV, counseling should help the woman/couple to accept an HIV test result and discuss implications for treatment.
EXPERIMENTAL: SoC + stigma counseling (Maisha); 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.	Behavioral: Mashia; Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Care Engagement (Female HIV-infected Participants Only)	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.	Post-assessment (3 months after enrollment)
Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)	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.	Post-assessment (3 months after enrollment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Assurance (QA Data)	Quality assurance data will be collected on feasibility, acceptability, and fidelity of Maisha session to the intervention manual. Sessions will be recorded and a subset of recordings will be reviewed to assess whether core components of the sessions were completed. Follow-up surveys will include items on participant satisfaction with the intervention format, session content, and interventionist. A subset of participants will also be selected to give additional qualitative feedback.	Post-assessment (3 months after enrollment)

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Fogarty International Center of the National Institute of Health; Kilimanjaro Christian Medical Centre, Tanzania
• Investigators: Principal Investigator: Melissa Watt, PhD, University of Utah; Principal Investigator: Blandina Mmbaga, MD, PhD, Kilimanjaro Christian Medical Centre

Publications and helpful links

General Publications

• Watt MH, Knettel BA, Knippler ET, Kisigo G, Ngocho JS, Renju J, Rogathi J, Sao SS, Minja L, Osaki H, Mwamba RN, Mmbaga BT. The development of Maisha, a video-assisted counseling intervention to address HIV stigma at entry into antenatal care in Tanzania. Eval Program Plann. 2020 Dec;83:101859. doi: 10.1016/j.evalprogplan.2020.101859. Epub 2020 Aug 5.
• Watt MH, Minja L, Knettel BA, Mwamba RN, Osaki H, Ngocho JS, Kisigo GA, Renju J, Vissoci JRN, Sao SS, Mmbaga BT. Pilot Outcomes of Maisha: An HIV Stigma Reduction Intervention Developed for Antenatal Care in Tanzania. AIDS Behav. 2021 Apr;25(4):1171-1184. doi: 10.1007/s10461-020-03093-9. Epub 2020 Nov 12.
• Watt MH, Knippler ET, Minja L, Kisigo G, Knettel BA, Ngocho JS, Renju J, Osaki H, Mwamba R, Rogathi JJ, Mmbaga BT. A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):807. doi: 10.1186/s13063-019-3933-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Counseling; HIV; Pregnancy; Tanzania; Stigma; Cognitive-behavioral therapy; Retention in care; Prevention of mother to child transmission
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 1R21TW011053-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data from the formative and pilot trial work in this R21 will be shared within the constraints required for the protection of confidentiality for study subjects. With a data transfer agreement from our Institutional Review Board, the investigators are willing to share raw data with researchers and program leaders from other institutions.
• IPD Sharing Time Frame: Data will be shared starting 6 months after publication.
• IPD Sharing Access Criteria: Data will be shared with investigators who are interested in secondary data analysis or inclusion in meta-analyses. The investigators will work with individuals requesting data access to put in place an appropriate data transfer agreement. The study PI will review all requests for data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No