Substance UseNCT06158607
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
A study testing Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders in people with Substance Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Substance Use
- What is being tested?
- Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
- 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
- 7 Jun 2022to 30 May 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Black/African American and Hispanic/Latina cisgender women
- diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
- 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
- able to speak, read, and write in English; and
- own or have regular access to a smart phone.
Who cannot join
- be concurrently participating in another SUD behavioral treatment program
- unable to provide informed consent for participation (e.g., 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
- be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
- have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).
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, 7134862830, Angela.M.Heads@uth.tmc.edu
Kaixuan An, (713) 486-2700, Kaixuan.An@uth.tmc.edu
About this study
Official title: Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is:
- If the integrated intervention increase PrEP uptake and adherence compared to standard treatment
Participants will
- receive provision of PrEP information through 4 counseling sessions
- prevention navigation
- receive nurse practitioner prescribed PrEP in an addiction treatment setting
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
- Conditions
- Substance Use
- Being tested
- Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders, Standard of care treatment
- 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.
Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use DisordersBehavioural
Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
Standard of care treatmentOther
Participants in substance use 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 |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders |
| Standard of care treatment | Active comparator | Not described Receives: Other: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider
Measured: 12 weeks post intervention
Secondary outcomes (7)
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations
levels of tenofovir (TFV) urine concentrations (>1000ng/ml) detected in urine shows higher adherence
Measured: 90 days post PrEP initiation
Daily PrEP adherence as assessed by the proportion of videos uploaded
Measured: 12 weeks post PrEP initiation
Daily PrEP adherence as assessed by the proportion of self reported daily adherence
Measured: 12 weeks post PrEP initiation
Enrollment rate as assessed by the number of participants that signed the consent form
Measured: 12 weeks post intervention
Number of sessions attended by participants
Measured: 12 weeks post enrollment
Study retention as assessed by the number of participants that completed the study
Measured: 12 weeks post enrollment
Intervention acceptability as assessed by the Client satisfaction questionnaire
This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction
Measured: 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start7 Jun 2022
- Primary completion30 May 2025 (estimated)
- Study completion30 May 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
- 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
- NCT06158607
- Sponsor's protocol ID
- HSC-MS-21-0451
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2023
- 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, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961.
PubMed 40409752
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 an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06158607
- Acronym / sponsor ID
- HSC-MS-21-0451
- 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
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 6 Dec 2023 (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 test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is:
- If the integrated intervention increase PrEP uptake and adherence compared to standard treatment
Participants will
- receive provision of PrEP information through 4 counseling sessions
- prevention navigation
- receive nurse practitioner prescribed PrEP in an addiction treatment setting
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase 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 |
|---|---|---|
| Intervention | Experimental | Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders |
| Standard of care treatment | Active comparator | Other: Standard of care treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Black/African American and Hispanic/Latina cisgender women
- diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
- 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 (6 listed)
- be concurrently participating in another SUD behavioral treatment program
- unable to provide informed consent for participation (e.g., 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
- be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
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 |
|---|---|---|
| Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use DisordersProvision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting. | Behavioural | Intervention |
| Standard of care treatmentParticipants in substance use 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 of care treatment |
Primary outcome
PrEP uptake
Time frame: 12 weeks post intervention
Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider
7 secondary outcomes
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations
Time frame: 90 days post PrEP initiation
Daily PrEP adherence as assessed by the proportion of videos uploaded
Time frame: 12 weeks post PrEP initiation
Daily PrEP adherence as assessed by the proportion of self reported daily adherence
Time frame: 12 weeks post PrEP initiation
Enrollment rate as assessed by the number of participants that signed the consent form
Time frame: 12 weeks post intervention
Number of sessions attended by participants
Time frame: 12 weeks post enrollment
Study retention as assessed by the number of participants that completed the study
Time frame: 12 weeks post enrollment
Intervention acceptability as assessed by the Client satisfaction questionnaire
Time frame: 12 weeks 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 30 Dec 2024.
- Derived from this study: PubMed 40409752Heads AM, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961.
- 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 Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders 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 7 inclusion and 6 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 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?
PrEP uptake (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 NCT06158607, 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.