Health Risk BehaviorsNCT07181616
Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women
A study testing Adapted W2W in people with Health Risk Behaviors, run by Laneshia Conner at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a group-based HIV prevention program can improve HIV knowledge, prevention behaviors, and testing in older Black women aged 50 and older who live in subsidized housing. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Risk Behaviors
- What is being tested?
- Adapted W2W
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to Jul 2030
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 50 years of age
- A resident of Selected sites
- A MOCA score of less than 24
- Self-identifying as an African American woman
- English speaking
Who cannot join
- Pre-menopausal
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn whether a group-based HIV prevention program can improve HIV knowledge, prevention behaviors, and testing in older Black women aged 50 and older who live in subsidized housing. The study focuses on improving how HIV prevention programs address the unique needs and life experiences of older Black women.
The main questions it aims to answer are:
Read more
Can a revised HIV prevention intervention tailored to reproductive health histories improve HIV knowledge, condom use, and testing in older Black women?
Is the intervention feasible, acceptable, and engaging for participants?
The PI will compare a group of participants receiving the Woman-2-Woman (W2W) intervention to a wait-listed control group to see if the intervention leads to better HIV prevention outcomes.
Participants will:
Join a group-based HIV prevention program designed for older Black women
Be randomly assigned to either:
Start the intervention right away, or
Join a waitlist and start the program 4 weeks later
Take part in four weekly sessions that include group discussions, education, and skill-building activities
Share information about their reproductive health histories and sexual health decisions during focus groups or surveys
Complete questionnaires at the start, after the program ends, and 4 weeks later to assess HIV knowledge, condom use, and testing behavior
This research aims to create a culturally tailored, evidence-based HIV intervention that fits the lives and needs of older Black women and can be used in future, larger studies.
- Conditions
- Health Risk Behaviors
- Being tested
- Adapted W2W, Waitlist Control
- Keywords
- HIV, Health Education, Health Equity
- Medical subject headings
- Health Risk Behaviors, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted W2WBehavioural
HIV education sessions and questionnaires.
Waitlist ControlBehavioural
HIV education sessions and questionnaires given 4 weeks after W2W intervention.
| Study group | Role | What they receive |
|---|---|---|
| Adapted W2W | Experimental | HIV intervention focused on aging-related HIV knowledge, identifying HIV prevention practices, and reducing HIV transmission. Intervention given in four, 2 hour educational sessions with a fifth booster session and a final follow up session. Receives: Behavioral: Adapted W2W |
| Waitlist Control | Active comparator | This group will receive the intervention 8 weeks after the W2W intervention group completes their follow-up and in the same pattern. Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Feasibility will be measured by recruitment rate (number of participants who sign the informed consent divided by those participants who meet the eligibility criteria)
Measured: Baseline
Acceptability
Acceptability will be measured by program satisfaction evaluations. Participants rate statements (1-5) with higher scores equating to greater satisfaction.
Measured: Assessed at weeks 1,2,3,4, 8 and 12
Retention Rate
Feasibility will also be measured by retention rate (number of participants who complete all 4 sessions divided by those participants who signed the informed consent)
Measured: Baseline (week 1) and Post-Intervention (Week 8)
Change in HIV Knowledge
HIV knowledge will be measured by the HIV-KQ-18. Scores range from 0-18 with higher scores equating to greater HIV knowledge.
Measured: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
Change in Condom-use self-efficacy (CUSES)
CUSES is a 28 item scale that will assess behavioral intentions and past behavior related to feelings about purchasing, using, and negotiating use of condoms with a new partner. Each item has a 5-point response format ranging from 0 (strongly disagree) to 4 (strongly agree). After reversing negatively worded items, scores range from 0-112 (with higher scores indicating more self-efficacy).
Measured: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
Change in H-AGE scale
The H-AGE scale is a gender and aging specific HIV knowledge scale with 6 items that assess participants knowledge of gender and age related issues regarding HIV. Q1 is a true/false question; Q2 \& 3 are multiple choice questions; Q4 is rating of strongly disagree (1) to strongly agree (5); Q5 is rating very comfortable (1)to very uncomfortable (5); Q6 they select one from the following (positive, negative, mixed, neutral)
Measured: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Nov 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Risk BehaviorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laneshia Conner
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Laneshia Conner, University of Kentucky
- Investigators
- Laneshia Conner, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181616
- Sponsor's protocol ID
- 78084
- Other IDs
- K01AG092253-01A1
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women
- ClinicalTrials.gov ID
- NCT07181616
- Acronym / sponsor ID
- 78084
- Conditions
- Health Risk Behaviors
- Keywords
- HIV, Health Education, Health Equity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laneshia ConnerUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 18 Sep 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 goal of this clinical trial is to learn whether a group-based HIV prevention program can improve HIV knowledge, prevention behaviors, and testing in older Black women aged 50 and older who live in subsidized housing. The study focuses on improving how HIV prevention programs address the unique needs and life experiences of older Black women.
The main questions it aims to answer are:
Can a revised HIV prevention intervention tailored to reproductive health histories improve HIV knowledge, condom use, and testing in older Black women?
Is the intervention feasible, acceptable, and engaging for participants?
The PI will compare a group of participants receiving the Woman-2-Woman (W2W) intervention to a wait-listed control group to see if the intervention leads to better HIV prevention outcomes.
Participants will:
Join a group-based HIV prevention program designed for older Black women
Be randomly assigned to either:
Start the intervention right away, or
Join a waitlist and start the program 4 weeks later
Take part in four weekly sessions that include group discussions, education, and skill-building activities
Share information about their reproductive health histories and sexual health decisions during focus groups or surveys
Complete questionnaires at the start, after the program ends, and 4 weeks later to assess HIV knowledge, condom use, and testing behavior
This research aims to create a culturally tailored, evidence-based HIV intervention that fits the lives and needs of older Black women and can be used in future, larger studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted W2W | Experimental | Behavioral: Adapted W2WHIV intervention focused on aging-related HIV knowledge, identifying HIV prevention practices, and reducing HIV transmission. Intervention given in four, 2 hour educational sessions with a fifth booster session and a final follow up session. |
| Waitlist Control | Active comparator | Behavioral: Waitlist ControlThis group will receive the intervention 8 weeks after the W2W intervention group completes their follow-up and in the same pattern. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 50 years of age
- A resident of Selected sites
- A MOCA score of less than 24
- Self-identifying as an African American woman
- English speaking
Key exclusion criteria (2 listed)
- Pre-menopausal
- Cognitive impairment
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 |
|---|---|---|
| Adapted W2WHIV education sessions and questionnaires. | Behavioural | Adapted W2W |
| Waitlist ControlHIV education sessions and questionnaires given 4 weeks after W2W intervention. | Behavioural | Waitlist Control |
Primary outcome
Recruitment rate
Time frame: Baseline
Feasibility will be measured by recruitment rate (number of participants who sign the informed consent divided by those participants who meet the eligibility criteria)
Acceptability
Time frame: Assessed at weeks 1,2,3,4, 8 and 12
Acceptability will be measured by program satisfaction evaluations. Participants rate statements (1-5) with higher scores equating to greater satisfaction.
Retention Rate
Time frame: Baseline (week 1) and Post-Intervention (Week 8)
Feasibility will also be measured by retention rate (number of participants who complete all 4 sessions divided by those participants who signed the informed consent)
Change in HIV Knowledge
Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
HIV knowledge will be measured by the HIV-KQ-18. Scores range from 0-18 with higher scores equating to greater HIV knowledge.
Change in Condom-use self-efficacy (CUSES)
Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
CUSES is a 28 item scale that will assess behavioral intentions and past behavior related to feelings about purchasing, using, and negotiating use of condoms with a new partner. Each item has a 5-point response format ranging from 0 (strongly disagree) to 4 (strongly agree). After reversing negatively worded items, scores range from 0-112 (with higher scores indicating more self-efficacy).
Change in H-AGE scale
Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)
The H-AGE scale is a gender and aging specific HIV knowledge scale with 6 items that assess participants knowledge of gender and age related issues regarding HIV. Q1 is a true/false question; Q2 \& 3 are multiple choice questions; Q4 is rating of strongly disagree (1) to strongly agree (5); Q5 is rating very comfortable (1)to very uncomfortable (5); Q6 they select one from the following (positive, negative, mixed, neutral)
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Laneshia Conner, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted W2W in people with Health Risk Behaviors, run by Laneshia Conner at 1 site in United States.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Aug 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 United States. 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?
Contact Laneshia Conner, PhD (859-562-3355, laneshia.conner@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 6 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 12 Aug 2026.