HIV PreventionWISEWOMANNCT07003789
Co-Developing an HIV Prevention Program for Women in Ghana
A study testing Women-Centered HIV Prevention Program in people with HIV Prevention and Women's Health, run by State University of New York at Buffalo at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Women's Health, Sexual and Reproductive Health
- What is being tested?
- Women-Centered HIV Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGhana
- Study dates
- 1 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Women-Centered HIV Prevention Program
- Keywords
- HIV self-testing (HIVST), Pre-exposure prophylaxis (PrEP), Youth-centered design, Sub-Saharan Africa, AGYW (Adolescent Girls and Young Women), HIV Stigma, Ghana
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women-Centered HIV Prevention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Women-Centered HIV Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: Week 5
Secondary outcomes (3)
Reduction in HIV-Related Stigma (Survey Score Change)
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
Measured: Baseline to Week 8
Number of Participants Reporting the WhatsApp-Based Intervention is Sustainable and Scalable
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
Measured: Week 6-8 (exit interviews)
Perceived Appropriateness of the Intervention (IAM Score)
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)
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Aidoo-Frimpong, State University of New York at Buffalo
- Investigators
- Gloria A Aidoo-Frimpong, PhD, MPH, MA, Principal investigator, SUNY BUFFALO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003789
- Sponsor's protocol ID
- STUDY00009328
- Acronym
- WISEWOMAN
- Status last verified
- Jan 2026
- First submitted
- 12 May 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the data related to HIV status, stigma, and participant privacy-especially within a small, community-based sample-individual participant data (IPD) will not be shared to protect confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07003789
- Acronym / sponsor ID
- WISEWOMAN / STUDY00009328
- Keywords
- HIV self-testing (HIVST), Pre-exposure prophylaxis (PrEP), Youth-centered design, Sub-Saharan Africa, AGYW (Adolescent Girls and Young Women), HIV Stigma, Ghana
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Women-Centered HIV Prevention Group | Experimental | Behavioral: Women-Centered HIV Prevention ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women-Centered HIV Prevention ProgramThis 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. | Behavioural | Women-Centered HIV Prevention Group |
Primary outcome
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)
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)
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)
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)
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 (%)
3 secondary outcomes
Reduction in HIV-Related Stigma (Survey Score Change)
Time frame: Baseline to Week 8
Number of Participants Reporting the WhatsApp-Based Intervention is Sustainable and Scalable
Time frame: Week 6-8 (exit interviews)
Perceived Appropriateness of the Intervention (IAM Score)
Time frame: Week 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data related to HIV status, stigma, and participant privacy-especially within a small, community-based sample-individual participant data (IPD) will not be shared to protect confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria A Aidoo-Frimpong, PhD, MPH, MA principal investigator
SUNY BUFFALO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women-Centered HIV Prevention Program in people with HIV Prevention and Women's Health, run by State University of New York at Buffalo at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by FIM Score (time frame: Week 5 (end of intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.