Co-Developing an HIV Prevention Program for Women in Ghana

NCT07003789 | Active Not Recruiting

• 1 other identifier: STUDY00009328
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The WISE Woman Study is a research project in Ghana focused on improving HIV prevention among young women aged 18 to 35. In Ghana, young women are at higher risk of HIV but often lack access to the right information and services. This study will first work with young women and community partners to co-develop a youth-friendly and women-centered HIV prevention program. The program will focus on two proven strategies: HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), a medicine that helps prevent HIV. After the program is created, researchers will test it with 50 young women in Greater Accra and the Eastern Region to see if it's acceptable, easy to use, and if it helps increase knowledge and use of HIVST and PrEP. The intervention will be delivered through WhatsApp and community-based workshops to ensure privacy and reach. Participants will complete surveys and take part in discussions and interviews to share their feedback. This research will help build better HIV prevention strategies tailored to the needs of young women in Ghana.

Conditions

HIV Prevention; Women's Health; Sexual and Reproductive Health

Keywords

HIV self-testing (HIVST); Pre-exposure prophylaxis (PrEP); Youth-centered design; Sub-Saharan Africa; AGYW (Adolescent Girls and Young Women); HIV Stigma; Ghana

Outcome Measures

Primary Outcomes (5)

• Feasibility as Measured by FIM Score

  Feasibility of the intervention will be measured using the Feasibility of Intervention Measure (FIM), a validated 4-item scale. Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores will be summarized using means and standard deviations. Higher scores indicate greater feasibility. Unit of Measure: Mean FIM score (1-5 scale)

  Week 5 (end of intervention)

• Acceptability as Measured by AIM Score

  Acceptability of the intervention will be measured using the Acceptability of Intervention Measure (AIM), a validated 4-item scale with 5-point Likert responses. Scores range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability. Results will be reported as mean and standard deviation. Unit of Measure: Mean AIM score (1-5 scale)

  Week 5 (post-intervention)

• Uptake of HIV self-testing (HIVST)

  Defined as the number of participants who report completing an HIV self-test during the study period, verified via WhatsApp photo confirmation or verbal report. Unit of Measure: Number of participants (count)

  Baseline to Week 8

• Willingness to Use PrEP (Survey-Based Behavioral Intention)

  Willingness will be measured using a validated PrEP intention scale in pre- and post-surveys (e.g., "I am likely to take PrEP in the next 3 months"). Items are scored on a 1 to 5 Likert scale, with higher scores indicating greater willingness to use PrEP. Change in mean intention scores will be reported. Unit of Measure: Mean change in score (1-5 scale)

  Baseline to Week 8

• Intervention Completion Rate

  Defined as the percentage of participants who complete all required activities during the 4-week WhatsApp-based intervention, including pre- and post-surveys. Unit of Measure: Percentage of participants (%)

  Week 5

Secondary Outcomes (3)

• Reduction in HIV-Related Stigma (Survey Score Change)

  Baseline to Week 8

• Number of Participants Reporting the WhatsApp-Based Intervention is Sustainable and Scalable

  Week 6-8 (exit interviews)

• Perceived Appropriateness of the Intervention (IAM Score)

  Week 5

Study Arms (1)

Women-Centered HIV Prevention Group

EXPERIMENTAL

Participants will take part in a co-developed HIV prevention intervention created through participatory workshops. The intervention will be delivered via WhatsApp over 4 weeks and will include HIV prevention messaging, discussion prompts, and peer support to improve awareness and uptake of HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), and reduce stigma.

Behavioral: Women-Centered HIV Prevention Program

Interventions

Women-Centered HIV Prevention Program BEHAVIORAL

This behavioral intervention consists of a participatory, youth-designed HIV prevention program that uses Human-Centered Design (HCD) principles and WhatsApp-based engagement. It includes information and support for HIV self-testing and PrEP, with the goal of increasing awareness, improving uptake, and reducing stigma among young women in Ghana.

Women-Centered HIV Prevention Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Identify as female and be between 18-35 years of age
• Reside in Greater Accra or the Eastern Region of Ghana
• Be sexually active (defined as having engaged in vaginal, anal, or oral sex in the past 6 months)
• Have access to a mobile phone with WhatsApp
• Be willing to provide informed consent
• Be interested in participating in HIV prevention activities
• Be comfortable discussing sexual and reproductive health in a group setting (for the workshop)
• For pilot phase only: must not have participated in the co-development workshop

You may not qualify if:

• Do not reside in the two specified regions of Ghana
• Unable to provide informed consent
• Have cognitive impairments or severe mental health conditions limiting participation
• Community partners with commercial conflicts of interest (for workshop only)

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

EARC

Accra, Ghana

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Gloria A Aidoo-Frimpong, PhD, MPH, MA

  SUNY BUFFALO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is used in this study. All participants and study staff are aware of the intervention.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A mixed-methods, community-based participatory intervention. Participants co-develop the HIV prevention program and then pilot test it through WhatsApp-based activities.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)