Clinical trial NCT07003789: Co-Developing an HIV Prevention Program for Women in Ghana
Official title: Co-Developing a Women-Centered HIV Prevention Intervention to Reduce Stigma, Increase HIV Self-Testing, and Improve PrEP Awareness and Uptake in Ghana
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A mixed-methods, community-based participatory intervention. Participants co-develop the HIV prevention program and then pilot test it through WhatsApp-based activities.
Primary purpose: PREVENTION

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.

Detailed description: Young women in Ghana face some of the highest risks of HIV infection in the country, yet they often lack access to HIV prevention tools and supportive services that are tailored to their needs. Many of the barriers they face-including stigma, low awareness, and limited youth-friendly options-can prevent them from accessing HIV self-testing (HIVST) or pre-exposure prophylaxis (PrEP), which are proven prevention methods.

The WISE Woman Study seeks to address these barriers by engaging young women as equal partners in the design and implementation of an HIV prevention intervention. The study is based on the idea that solutions are more effective when they are created with the community, not for it. It uses participatory methods to involve young women in shaping the intervention and includes two main phases:

Phase 1 - Co-Development Workshop:

Fifteen participants-including ten young women and five community stakeholders (such as healthcare workers or peer educators)-will take part in a full-day participatory workshop. During this workshop, they will identify key barriers to HIV prevention, co-create solutions, and help design the structure of the intervention. Structured methods such as the Nominal Group Technique (NGT) and Human-Centered Design (HCD) will be used to ensure that all voices are heard and that the final program reflects the participants' preferences and lived experiences.

Phase 2 - Pilot Study:

Fifty young women aged 18-35 will participate in a 4-week pilot study to test the feasibility and acceptability of the co-developed intervention. Participants will receive information, support, and discussion prompts through WhatsApp-a platform commonly used in Ghana. They will complete short surveys before and after the intervention, and a subset will take part in in-depth interviews to reflect on their experiences. The study will look at changes in knowledge and attitudes toward HIV prevention, willingness to use HIVST and PrEP, and whether participants feel more empowered to take charge of their sexual health.

This study is designed with privacy, respect, and participant safety in mind. By using a mobile platform and focusing on community co-creation, the WISE Woman Study offers an innovative approach to strengthening HIV prevention among young women in Ghana. The findings will help inform future HIV programs and may serve as a model for youth-centered public health interventions in similar settings.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Feasibility as Measured by FIM Score
timeFrame: Week 5 (end of intervention)
measure: Acceptability as Measured by AIM Score
timeFrame: Week 5 (post-intervention)
measure: Uptake of HIV self-testing (HIVST)
timeFrame: Baseline to Week 8
measure: Willingness to Use PrEP (Survey-Based Behavioral Intention)
timeFrame: Baseline to Week 8
measure: Intervention Completion Rate
timeFrame: Week 5
Secondary outcomes:
measure: Reduction in HIV-Related Stigma (Survey Score Change)
timeFrame: Baseline to Week 8
measure: Number of Participants Reporting the WhatsApp-Based Intervention is Sustainable and Scalable
timeFrame: Week 6-8 (exit interviews)
measure: Perceived Appropriateness of the Intervention (IAM Score)
timeFrame: Week 5
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: EARC
Study officials:
affiliation: SUNY BUFFALO
name: Gloria A Aidoo-Frimpong, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References: