Recruiting

PrEP Intervention

Sponsor:

San Francisco Department of Public Health

Code:

NCT04523519

Conditions

HIV Infections

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Video directly observed therapy with contingency management

Integrated Next-Step Counseling

Study Details

Brief summary:

In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks.

The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use.

We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP.

Conditions

HIV Infections

Study ID

NCT04523519

Start date

Apr 30, 2021

Status verified date

May, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Age 18-65 years inclusive,
2. Assigned male sex at birth,
3. Past 30-day methamphetamine use on 4 or more days, by self-report,
4. ≥ 1 positive methamphetamine urine toxicology,
5. Either interested in initiating PrEP OR currently on daily PrEP with sub-optimal adherence (measured as missing at least one dose of one's PrEP in the past 30 days, by self-report),
6. Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months,
7. HIV-negative,
8. Reliable access to a computer to complete study visits, if participating remotely, AND
9. Proficient in English

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. On PrEP for more than 6 months,
2. Unwillingness to use a video app to record oneself taking PrEP, OR
3. Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.

For participants receiving PrEP from the study team, exclusion criteria will include the following:
4. Contraindication to tenofovir or emtricitabine-containing products,
5. Creatinine clearance ≤30 mL/min, OR
6. Positive hepatitis B surface antigen test.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Video directly observed therapy with contingency management

Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling.

placebo comparator: Integrated Next-Step Counseling

Interventions

Video directly observed therapy with contingency management

PrEP adherence will be assessed by visual recognition software during video capture and reviewed for confirmation by study staff, ensuring that videos demonstrate study medication dosing by participant. Participants will receive small financial incentives upon confirmation of dosing.

Integrated Next-Step Counseling

Integrated Next-Step Counseling combines support for behavioral strategies that reduce sexual and injection-related HIV risk and do not involve PrEP, with strategies to support PrEP adherence in brief, client-centered conversations.

Primary outcome measure

  • Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots [ Time Frame: Week 6 ]
  • TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots [ Time Frame: Week 12 ]
  • TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots [ Time Frame: Week 18 ]
  • TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Locations

San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94102

Contacts

More Information

Sponsor

San Francisco Department of Public Health

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Francisco Department of Public Health on 2024-05-16.