Promoting Reductions in Intersectional StigMa (PRISM) - GHANA

NCT04108078 | Completed

• 2 other identifiers: 20000259171R01NR019009-01
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 1

Brief Summary

HIV prevalence among men with have sex with men (MSM) in Ghana is at least eight times higher than that of the general population (2%). MSM in Ghana face high levels of stigma due to HIV status (actual or perceived), same-sex behavior, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. In our preliminary work in Ghana (N=137), one-third of MSM had never been tested for HIV. This study is a randomized controlled trial to evaluate the feasibility, acceptability and estimate effect size of a multi-component, multi-level (organizational, interpersonal, and intrapersonal-level) intersectional stigma-reduction intervention to increase HIV testing frequency among MSM in Ghana where HIV, same-sex behavior and gender non-conformity are highly stigmatized. To date, stigma-reduction interventions in Ghana have focused on uni-level targets (e.g., health care facilities (HCFs)) and addressed one type of stigma (e.g., HIV), without engaging the intersectional character of the multiple stigmas that MSM encounter. Our specific aims are:

1. 1.to evaluate the feasibility and acceptability of a novel multi-component, multi-level intervention to address intersectional stigma.
2. 2.to estimate effect size of the intervention for scale up to a definitive efficacy trial.

Conditions

HIV; Stigma

Keywords

HIV; Stigma; Intersectional Stigma; Men who have sex with men

Outcome Measures

Primary Outcomes (2)

• HIV testing frequency (for MSM)

  The intervention will be assessed in the number of completed HIV tests at 3 months compared to baseline. We will combine non-duplicative numbers of self-report and clinic-verified HIV tests (verification is only if an MSM had an HIV test performed at one of the healthcare facilities participating in the multi-level intervention) we are only measuring this outcome with MSM.

  Change from baseline at 3 months post- intervention

• HIV testing frequency (for MSM)

  The intervention will be assessed in the number of completed HIV tests at 6 months compared to baseline. We will combine non-duplicative numbers of self-report and clinic-verified HIV tests (verification is only if an MSM had an HIV test performed at one of the healthcare facilities participating in the multi-level intervention) we are only measuring this outcome with MSM.

  Change from baseline at 6 months post- intervention

Study Arms (2)

Intervention

EXPERIMENTAL

This arm consists of 1) MSM who receive the intervention (not wait listed) and healthcare facility staff who work at health facilities that have been chosen for the intervention.

Behavioral: Health Policy Plus (HP+); Behavioral: Many Men Many Voices (3MV); Behavioral: HIV Education, Empathy and Empowerment (HIVE3)

Wait listed

NO INTERVENTION

Participants in this arm (MSM and staff at health facilities that were wait listed) will complete assessments, but will receive the intervention after the experimental arm of the study.

Interventions

Health Policy Plus (HP+) BEHAVIORAL

HP+ is a stigma-reduction intervention that is designed to reduce stigmatizing attitudes and beliefs among all workers (clinical and non- clinical) in a healthcare facility.

Intervention

Many Men Many Voices (3MV) BEHAVIORAL

3MV is a group-level HIV prevention intervention designed specifically for use with Black men who have sex with men (MSM). It is a 7- session intervention that is facilitated by trained peers. The intervention has previously been adapted and used with MSM in Ghana.

Intervention

HIV Education, Empathy and Empowerment (HIVE3) BEHAVIORAL

The HIVE3 is a telephone-based peer support intervention. It utilizes trained peers, who are also MSM, to provide emotional, informational and affirming support via text message or phone. The intervention was developed specifically for use with MSM in Ghana and demonstrated acceptability and feasibility in a preliminary study in Ghana.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Part of the study sample will consist only of Ghanaian men who have sex with men. Healthcare facility staff will consist of both men and women. An estimated 70% of healthcare facility staff are female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the RCT, HCF staff are eligible to participate in the study if they are:
• \* Employed at one of the eight facilities identified for this study and identified with a potential to encounter MSM clients.
• For the RCT, MSM are eligible to participate in the study if they are:
• Biologically male at birth
• Currently self-identify as cisgender man
• Report sexual activity with another man at least once within the previous six months and report that they are HIV-negative or status unknown.

You may not qualify if:

• HCF staff will be excluded if they anticipate leaving work at the HCF during the study period or have previously participated in HP.
• MSM will be excluded if they plan to move out of the area during the study period.
• \*\*\*Focus Group Discussions (FGDs)\*\*\*
• HCF staff are eligible to participate in the FGDs if they are:
• \* Employed at a study participating facility.
• MSM are eligible to participate in FGDs if they are:
• years or older
• Biologically male at birth
• Currently self-identified as cisgender man
• \*\*\*In-Depth Interviews (IDI)\*\*\*
• HCF staff are eligible to participate if they are:
• Trained in Health Policy Plus (HP+)
• Have previously delivered HP+ in a Ghanaian HCF
• MSM are eligible to participate if:
• years or older

Sponsors & Collaborators

• Yale University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Ghana School of Public Health

Accra, Greater Accra Region, Ghana

Location

Related Publications (1)

• Nelson LE, Nyblade L, Torpey K, Logie CH, Qian HZ, Manu A, Gyamerah E, Boakye F, Appiah P, Turner D, Stockton M, Abubakari GM, Vlahov D. Multi-level intersectional stigma reduction intervention to increase HIV testing among men who have sex with men in Ghana: Protocol for a cluster randomized controlled trial. PLoS One. 2021 Nov 29;16(11):e0259324. doi: 10.1371/journal.pone.0259324. eCollection 2021.

  PMID: 34843529 DERIVED

MeSH Terms

Conditions

Social Stigma; Homosexuality

Interventions

Health Policy

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Sexuality; Sexual Behavior

Intervention Hierarchy (Ancestors)

Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Officials

• LaRon E. Nelson, PhD

  Yale School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 27, 2019
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

GH (1)