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NCT Number: NCT07003789

Co-Developing an HIV Prevention Program for Women in Ghana

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Prevention Behavior Coitus Sexual Behavior Sexual and Reproductive Health Women's Health

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

EARC

Accra, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Feasibility as Measured by FIM Score

    Time frame: Week 5 (end of intervention)

    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)

  2. Acceptability as Measured by AIM Score

    Time frame: Week 5 (post-intervention)

    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)

  3. Uptake of HIV self-testing (HIVST)

    Time frame: Baseline to Week 8

    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)

  4. Willingness to Use PrEP (Survey-Based Behavioral Intention)

    Time frame: Baseline to Week 8

    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)

  5. Intervention Completion Rate

    Time frame: Week 5

    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 (%)

Secondary outcomes

  1. Reduction in HIV-Related Stigma (Survey Score Change)

    Time frame: Baseline to Week 8

    HIV-related stigma will be measured using an adapted multi-item stigma scale (e.g., internalized and anticipated stigma). Change from pre- to post-intervention will be reported. Scores will be reported as mean change from pre- to post-intervention. The scale ranges from 1 (low stigma) to 5 (high stigma). Lower scores indicate a reduction in stigma (better outcome).

    Unit of Measure: Mean change in stigma score

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

    Time frame: Week 6-8 (exit interviews)

    Assessed qualitatively via thematic analysis of exit interviews. Participants will be asked if the WhatsApp format and intervention content could be maintained and scaled in their community. Themes will be summarized narratively.

    Unit of Measure: Not applicable - qualitative outcome

  3. Perceived Appropriateness of the Intervention (IAM Score)

    Time frame: Week 5

    Appropriateness of the intervention will be measured using the Intervention Appropriateness Measure (IAM), a validated 4-item scale with 5-point Likert responses. Scores range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater perceived appropriateness. Results will be reported as mean and standard deviation.

    Unit of Measure: Mean IAM score (1-5 scale)

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Co-Developing a Women-Centered HIV Prevention Intervention to Reduce Stigma, Increase HIV Self-Testing, and Improve PrEP Awareness and Uptake in Ghana

Acronym: WISEWOMAN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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