Substance UseNCT06558825
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
A study testing Integrated Intervention to Promote PrEP Uptake and Standard Treatment Condition in people with Substance Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use
- What is being tested?
- Integrated Intervention to Promote PrEP Uptake and Standard Treatment Condition
- 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
- 1 Oct 2024to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently undergoing mental health treatment;
- Have a history of trauma;
- HIV negative;
- Sexually active with an opposite sex partner within the past 6 months;
- Not using PrEP for HIV prevention at the time of screening;
- Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
- Fluent in English;
- Own or have regular access to a smart phone.
Who cannot join
- HIV positive;
- Concurrently participating in another HIV prevention program;
- Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
- Have psychological distress that would prohibit them from participating in the study;
- Be unable or unwilling to meet study requirements.
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, 1 recruiting
- Recruiting
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, 77054
Angela Heads, PhD, (713) 486-2830, Angela.M.Heads@uth.tmc.edu
Louis A. Faillace, MD, Department of Psychiatry and Behavioral An, MA, (713) 486-2531, Kaixuan.An@uth.tmc.edu
About this study
Official title: Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.
- Conditions
- Substance Use
- Being tested
- Integrated Intervention to Promote PrEP Uptake, Standard Treatment Condition
- Keywords
- Pre-Exposure Prophylaxis, Women, HIV Prevention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Intervention to Promote PrEP UptakeBehavioural
Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.
Standard Treatment ConditionOther
Participants in trauma treatment will be given information and referral to a community partner who will evaluate them to determine if they could benefit from PrEP for HIV prevention
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intervention to Promote PrEP Uptake | Experimental | Not described Receives: Behavioral: Integrated Intervention to Promote PrEP Uptake |
| Standard Treatment Condition | Active comparator | Not described Receives: Other: Standard Treatment Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who uptake PrEP
PrEP uptake is defined as obtaining a prescription and taking the first dose.
Measured: 12 weeks post intervention
Secondary outcomes (11)
Number of Participants who adhere to PrEP
PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (>1000ng/ml).
Measured: 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of videos uploaded
In the intervention arm, participants are asked to take a video of themselves taking PrEP. Videos are uploaded through an app, which is offered in the intervention arm only (and not the standard treatment arm). Data will be reported as the number of days a video is uploaded divided by the number of days of the intervention period.
Measured: from the time of PrEP initiation to 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of self-reported daily adherence
In both arms, participants are sent a questionnaires weekly in which they record the number of days they took PrEP over the past seven days. Data will be reported as the number of days PrEP is taken divided by the number of days of the intervention period.
Measured: from the time of PrEP initiation to 12 weeks post PrEP initiation
Intervention feasibility as assessed by number of participants enrolled
The number enrolled is the number of participants who signed the consent form.
Measured: at the time of enrollment
Intervention feasibility as assessed by number of sessions attended by participants
Measured: 15 weeks post enrollment
Intervention feasibility as assessed by study retention
Study retention is assessed by the the number of participants who completed the study.
Measured: 15 weeks post enrollment
Intervention acceptability as assessed by score on a satisfaction questionnaire
This is a 15 item questionnaire and each item is scored from 1 (not at all true) to 9 (absolutely true). Total score ranges from 15 to 135, with a higher score indicating greater satisfaction.
Measured: 15 weeks post enrollment
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale
Total score ranges from 8 to 32, with a higher score indicating greater stigma.
Measured: baseline, 15 weeks post enrollment
Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale
Total score ranges from 10 to 40, with a higher score indicating a greater perceived HIV risk.
Measured: baseline, 15 weeks post enrollment
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire
Total score ranges from 0 to 6, with a higher score indicating a greater knowledge about PrEP.
Measured: baseline, 15 weeks post enrollment
Change in PrEP attitudes as assessed by PrEP Attitudes Measure
Total score ranges from 5.2 to 26, with a higher score indicating a better attitude toward PrEP.
Measured: baseline, 15 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Angela M Heads, The University of Texas Health Science Center, Houston
- Investigators
- Angela Heads, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558825
- Sponsor's protocol ID
- HSC-MS-21-0544
- Other IDs
- 1R34DA055496-01
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heads AM, An K, Hill MJ, Gameon JA, de Dios C, Suchting R, Acierno R. Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2026 May 9;51:101645. doi: 10.1016/j.conctc.2026.101645. eCollection 2026 Jun.
PubMed 42200033
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions
- ClinicalTrials.gov ID
- NCT06558825
- Acronym / sponsor ID
- HSC-MS-21-0544
- Conditions
- Substance Use
- Keywords
- Pre-Exposure Prophylaxis, Women, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Aug 2024 (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 investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention to Promote PrEP Uptake | Experimental | Behavioral: Integrated Intervention to Promote PrEP Uptake |
| Standard Treatment Condition | Active comparator | Other: Standard Treatment Condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently undergoing mental health treatment;
- Have a history of trauma;
- HIV negative;
- Sexually active with an opposite sex partner within the past 6 months;
- Not using PrEP for HIV prevention at the time of screening;
Key exclusion criteria (5 listed)
- HIV positive;
- Concurrently participating in another HIV prevention program;
- Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
- Have psychological distress that would prohibit them from participating in the study;
- Be unable or unwilling to meet study requirements.
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 |
|---|---|---|
| Integrated Intervention to Promote PrEP UptakeProvision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting. | Behavioural | Integrated Intervention to Promote PrEP Uptake |
| Standard Treatment ConditionParticipants in trauma treatment will be given information and referral to a community partner who will evaluate them to determine if they could benefit from PrEP for HIV prevention | Other | Standard Treatment Condition |
Primary outcome
Number of participants who uptake PrEP
Time frame: 12 weeks post intervention
PrEP uptake is defined as obtaining a prescription and taking the first dose.
11 secondary outcomes
Number of Participants who adhere to PrEP
Time frame: 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of videos uploaded
Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of self-reported daily adherence
Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation
Intervention feasibility as assessed by number of participants enrolled
Time frame: at the time of enrollment
Intervention feasibility as assessed by number of sessions attended by participants
Time frame: 15 weeks post enrollment
Intervention feasibility as assessed by study retention
Time frame: 15 weeks post enrollment
Intervention acceptability as assessed by score on a satisfaction questionnaire
Time frame: 15 weeks post enrollment
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale
Time frame: baseline, 15 weeks post enrollment
Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale
Time frame: baseline, 15 weeks post enrollment
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire
Time frame: baseline, 15 weeks post enrollment
Change in PrEP attitudes as assessed by PrEP Attitudes Measure
Time frame: baseline, 15 weeks post enrollment
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 30 Dec 2024.
- Derived from this study: PubMed 42200033Heads AM, An K, Hill MJ, Gameon JA, de Dios C, Suchting R, Acierno R. Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2026 May 9;51:101645. doi: 10.1016/j.conctc.2026.101645. eCollection 2026 Jun.
- 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.
Angela Heads, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Intervention to Promote PrEP Uptake and Standard Treatment Condition in people with Substance Use, run by The University of Texas Health Science Center, Houston 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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 Angela M Heads, PhD ((713) 486-2830, Angela.M.Heads@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who uptake PrEP (time frame: 12 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558825, which also lists 1 linked publication.
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 30 Dec 2024.