Substance Use
Conditions
Keywords
Pre-Exposure Prophylaxis, Women, HIV Prevention
Brief 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.
Interventions
BEHAVIORALIntegrated Intervention to Promote PrEP Uptake
Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.
OTHERStandard Treatment Condition
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
Sponsors
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who uptake PrEP | 12 weeks post intervention | PrEP uptake is defined as obtaining a prescription and taking the first dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP adherence as assessed by proportion of videos uploaded | from the time of PrEP initiation to 12 weeks post PrEP initiation | 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. |
| PrEP adherence as assessed by proportion of self-reported daily adherence | from the time of PrEP initiation to 12 weeks post PrEP initiation | 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. |
| Intervention feasibility as assessed by number of participants enrolled | at the time of enrollment | The number enrolled is the number of participants who signed the consent form. |
| Intervention feasibility as assessed by number of sessions attended by participants | 15 weeks post enrollment | — |
| Intervention feasibility as assessed by study retention | 15 weeks post enrollment | Study retention is assessed by the the number of participants who completed the study. |
| Number of Participants who adhere to PrEP | 12 weeks post PrEP initiation | PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (\>1000ng/ml). |
| Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale | baseline, 15 weeks post enrollment | Total score ranges from 8 to 32, with a higher score indicating greater stigma. |
| Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale | baseline, 15 weeks post enrollment | Total score ranges from 10 to 40, with a higher score indicating a greater perceived HIV risk. |
| Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire | baseline, 15 weeks post enrollment | Total score ranges from 0 to 6, with a higher score indicating a greater knowledge about PrEP. |
| Change in PrEP attitudes as assessed by PrEP Attitudes Measure | baseline, 15 weeks post enrollment | Total score ranges from 5.2 to 26, with a higher score indicating a better attitude toward PrEP. |
| Intervention acceptability as assessed by score on a satisfaction questionnaire | 15 weeks post enrollment | 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. |
Countries
United States
Contacts
Primary ContactAngela M Heads, PhD
Backup ContactKaixuan An
Outcome results
None listed