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

NCT03600142 | Completed Results

• 1 other identifier: 1R21TW011053-01
• Study Type: interventional
• Target: 1,539
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Stigma; HIV; Counseling; Tanzania; Pregnancy; Cognitive-behavioral therapy; Retention in care; Prevention of mother to child transmission

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality Assurance (QA Data)

  Post-assessment (3 months after enrollment)

Study Arms (2)

Standard of Care (SoC)

NO INTERVENTION

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.

SoC + stigma counseling (Maisha)

EXPERIMENTAL

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

Interventions

Mashia BEHAVIORAL

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.

SoC + stigma counseling (Maisha)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Impaired mental status
• Does not speak Swahili

Sponsors & Collaborators

• University of Utah: lead
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Related Publications (4)

• 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.

  PMID: 32795711 BACKGROUND

• 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.

  PMID: 33180253 RESULT

• Cohen SR, Marchand V, Calkins K, Stephens MJ, Barabara ML, Minja LM, Olomi GA, Mlay J, Mlay PS, Hanson OR, Mmbaga BT, Watt MH. Participatory simulation training design: The MAMA interprofessional team-training program for obstetric care of pregnant individuals living with HIV in Tanzania. Eval Program Plann. 2025 Jun;110:102550. doi: 10.1016/j.evalprogplan.2025.102550. Epub 2025 Jan 31.

  PMID: 39914273 DERIVED

• 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.

  PMID: 31888700 DERIVED

MeSH Terms

Conditions

HIV Infections; Social Stigma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Melissa Watt
• Organization: University of Utah

melissa.watt@hsc.utah.edu

8015817201

Study Officials

• Melissa Watt, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Blandina Mmbaga, MD, PhD

  Kilimanjaro Christian Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Population Health Sciences

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: April 8, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 10, 2022
• Results First Posted: September 20, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared starting 6 months after publication.
• 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.

Locations

TA (1)