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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
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Standard of care treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders | Behavioral | Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days post PrEP initiation |
| Daily PrEP adherence as assessed by the proportion of videos uploaded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Heads, PhD | Contact | (713) 486-2830 | Angela.M.Heads@uth.tmc.edu | |
| Kaixuan An | Contact | (713) 486-2531 | Kaixuan.An@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Heads, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409752 | Derived | 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. |
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| Standard of care treatment | Other | 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 |
|
| 12 weeks post PrEP initiation |
| Daily PrEP adherence as assessed by the proportion of self reported daily adherence | 12 weeks post PrEP initiation |
| Enrollment rate as assessed by the number of participants that signed the consent form | 12 weeks post intervention |
| Number of sessions attended by participants | 12 weeks post enrollment |
| Study retention as assessed by the number of participants that completed the study | 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 | 12 weeks post intervention |
|
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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