Promoting Reductions in Intersectional StigMa (PRISM) - GHANA

NCT04108078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2023-03-06

No results posted yet for this study

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

Our primary endpoint are:

For MSM: HIV testing, intervention feasibility and acceptability For HCFs: intervention feasibility, acceptability and appropriateness

Our secondary endpoints are:

MSM: Intersectional stigma reduction HCF: Intersectional stigma reduction

This study will combine three theory-based interventions that were previously implemented separately in Ghana for reducing stigma at HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Convergence Framework will be used for combining interventions. The ADAPT-ITT framework guides our approach to enhancing the interventions' content on intersectional stigma. To achieve these aims a systematic adaptation that will be used to refine the individually developed HCF, peer- and individual-level interventions to produce a comprehensive multi-level intersectional stigma reduction intervention.

Conditions

Interventions

BEHAVIORAL

Health Policy Plus (HP+)

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.

BEHAVIORAL

Many Men Many Voices (3MV)

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.

BEHAVIORAL

HIV Education, Empathy and Empowerment (HIVE3)

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.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • LaRon E. Nelson, PhD · Yale School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04108078 on ClinicalTrials.gov