HIV InfectionsNCT07864766
SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV
A study testing SEPA+PrEP Women in people with HIV Infections, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis [PrEP]). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- SEPA+PrEP Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2027
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as a woman
- Age 18 years or older
- HIV-negative or unknown HIV status
- Report vaginal or anal sex with a male partner within the past 6 months
- Report at least one HIV risk factor
- Not currently using PrEP
- Able to provide informed consent
Who cannot join
- Does not meet the applicable inclusion criteria
- Currently using PrEP
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami School of Nursing and Health Studies
Coral Gables, Florida, 33147
About this study
Official title: Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV
The purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis [PrEP]). The study will assess whether women assigned to SEPA+PrEP-Women demonstrate higher PrEP uptake than controls and will generate initial effect size estimates to inform a future definitive trial.
- Conditions
- HIV Infections
- Being tested
- SEPA+PrEP Women
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEPA+PrEP WomenBehavioural
Participants will receive the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. The intervention focuses on HIV testing, PrEP awareness, PrEP decision-making, partner communication, HIV risk perception, stigma, relationship dynamics, intimate partner violence and safety considerations, substance use, and navigation of healthcare and community resources. Sessions include facilitated discussion, skills-building activities, role-play, interactive exercises, and peer support.
| Study group | Role | What they receive |
|---|---|---|
| SEPA+PrEP-Women Intervention | Experimental | Participants will receive the the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. Each session lasting approximately 2 hours. Receives: Behavioral: SEPA+PrEP Women |
| Delayed SEPA+PrEP-Women Intervention (Wait-List Control) | No intervention | Participants assigned to this arm will complete baseline, 1-month, and 3-month follow-up assessments and will not receive the SEPA+PrEP-Women intervention during the 3-month study period. After completing the 3-month follow-up assessment, participants will be offered the SEPA+PrEP-Women intervention, which consists of three weekly group sessions delivered via Zoom, with each session lasting approximately 2 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PreP Uptake
PrEP uptake is a binary composite endpoint defined as attendance at a PrEP initiation appointment and/or receipt of a PrEP prescription.
Measured: 1 month post-intervention, 3 months post-intervention
Intention to Initiate PrEP
Intention to initiate PrEP will be assessed using the 3-item PrEP Intention Scale. Scores range from 1 (Very unlikely) to 5 (Very likely), with higher scores indicating a greater intention to initiate PrEP.
Measured: Baseline, 1 month post-intervention, and 3 months post-intervention
Secondary outcomes (2)
Safe Sex Behavior Questionnaire (SSBQ) Total Score
Sexual HIV risk behaviors will be assessed using the 27-item Safe Sex Behavior Questionnaire (SSBQ), a validated self-report measure of HIV risk-reduction and safer sex behaviors. Items are scored from 1 (Never) to 5 (Always), with higher scores indicating greater engagement in safer sexual behaviors and lower sexual HIV risk.
Measured: Baseline, 1 month post-intervention, and 3 months post-intervention.
PrEP Knowledge Scale Total score
PrEP knowledge will be measured using the 13-item PrEP Knowledge Questionnaire. Scores range from 0 to 13, with higher scores indicating greater knowledge of PrEP.
Measured: Baseline, 1 month post-intervention, and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized in a 1:1 ratio to either the SEPA+PrEP-Women intervention or a delayed-intervention control group. The intervention group will receive the intervention immediately after baseline assessment. The control group will receive the intervention after completion of the 3-month follow-up interview.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosina Cianelli, University of Miami
- Investigators
- Joseph De Santis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864766
- Sponsor's protocol ID
- 20261141
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV
- ClinicalTrials.gov ID
- NCT07864766
- Acronym / sponsor ID
- 20261141
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Oct 2026 (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 purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis [PrEP]). The study will assess whether women assigned to SEPA+PrEP-Women demonstrate higher PrEP uptake than controls and will generate initial effect size estimates to inform a future definitive trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either the SEPA+PrEP-Women intervention or a delayed-intervention control group. The intervention group will receive the intervention immediately after baseline assessment. The control group will receive the intervention after completion of the 3-month follow-up interview.
| Arm | Type | Receives |
|---|---|---|
| SEPA+PrEP-Women Intervention | Experimental | Behavioral: SEPA+PrEP WomenParticipants will receive the the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. Each session lasting approximately 2 hours. |
| Delayed SEPA+PrEP-Women Intervention (Wait-List Control) | No intervention | –Participants assigned to this arm will complete baseline, 1-month, and 3-month follow-up assessments and will not receive the SEPA+PrEP-Women intervention during the 3-month study period. After completing the 3-month follow-up assessment, participants will be offered the SEPA+PrEP-Women intervention, which consists of three weekly group sessions delivered via Zoom, with each session lasting approximately 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identify as a woman
- Age 18 years or older
- HIV-negative or unknown HIV status
- Report vaginal or anal sex with a male partner within the past 6 months
- Report at least one HIV risk factor
Key exclusion criteria (3 listed)
- Does not meet the applicable inclusion criteria
- Currently using PrEP
- Unable to provide informed consent
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 |
|---|---|---|
| SEPA+PrEP WomenParticipants will receive the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. The intervention focuses on HIV testing, PrEP awareness, PrEP decision-making, partner communication, HIV risk perception, stigma, relationship dynamics, intimate partner violence and safety considerations, substance use, and navigation of healthcare and community resources. Sessions include facilitated discussion, skills-building activities, role-play, interactive exercises, and peer support. | Behavioural | SEPA+PrEP-Women Intervention |
Primary outcome
PreP Uptake
Time frame: 1 month post-intervention, 3 months post-intervention
PrEP uptake is a binary composite endpoint defined as attendance at a PrEP initiation appointment and/or receipt of a PrEP prescription.
Intention to Initiate PrEP
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention
Intention to initiate PrEP will be assessed using the 3-item PrEP Intention Scale. Scores range from 1 (Very unlikely) to 5 (Very likely), with higher scores indicating a greater intention to initiate PrEP.
2 secondary outcomes
Safe Sex Behavior Questionnaire (SSBQ) Total Score
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention.
PrEP Knowledge Scale Total score
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention.
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 13 Oct 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.
Joseph De Santis, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEPA+PrEP Women in people with HIV Infections, run by University of Miami 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 7 inclusion and 3 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 13 Oct 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 Rosina Cianelli, PhD (305 284 2147, rcianelli@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PreP Uptake (time frame: 1 month post-intervention, 3 months post-intervention). The study lists 2 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 13 Oct 2026.