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Behavioral Intervention

Integrated Intervention to Promote PrEP Uptake for Substance Abuse

N/A
Waitlist Available
Led By Angela Heads, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Currently undergoing mental health treatment;
* Have a history of trauma;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks post enrollment
Awards & highlights

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. 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.

Who is the study for?
This trial is for cisgender women receiving treatment for trauma-related mental health conditions who are at increased risk of HIV. Participants should be interested in a program to help them start and stick with PrEP, a medication that prevents HIV. Details on specific inclusion or exclusion criteria were not provided.
What is being tested?
The study tests an integrated intervention designed to encourage starting and maintaining use of PrEP within the context of mental health care for trauma. It will be compared with standard treatments to see if it's more effective, feasible, and acceptable.
What are the potential side effects?
Potential side effects were not specified but may include those commonly associated with PrEP medications such as nausea, headache, stomach pain, weight loss, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks post enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks post enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who uptake PrEP
Secondary study objectives
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale
Change in PrEP attitudes as assessed by PrEP Attitudes Measure
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Intervention to Promote PrEP UptakeExperimental Treatment1 Intervention
Group II: Standard Treatment ConditionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
926 Previous Clinical Trials
333,461 Total Patients Enrolled
1 Trials studying Substance Abuse
7,500 Patients Enrolled for Substance Abuse
National Institute on Drug Abuse (NIDA)NIH
2,522 Previous Clinical Trials
3,243,997 Total Patients Enrolled
153 Trials studying Substance Abuse
706,778 Patients Enrolled for Substance Abuse
Angela Heads, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
60 Total Patients Enrolled
~40 spots leftby Mar 2025
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