Clinical trial NCT04523519: PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Official title: PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-21
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: New HIV infections among people who inject drugs (PWID) are increasing in the United States and San Francisco. Methamphetamine is a driving force in the transmission of HIV. Multiple studies across diverse populations have found methamphetamine use to be independently associated with both injection and sexual risk behaviors for HIV acquisition. Men who have sex with men (MSM) who inject methamphetamine are at particularly elevated risk for HIV from both injection and sexual risk behaviors.

Daily, oral pre-exposure prophylaxis (PrEP) is safe and highly effective for HIV prevention when taken consistently. The Centers for Disease Control and other health agencies recommend PrEP for PWID. Despite this recommendation and increasing PrEP use in the US, almost no PrEP studies or demonstration projects have focused on PWID. The small number of studies that have evaluated PrEP use among MSM who inject methamphetamine have shown slow PrEP uptake and adherence challenges.

The PRIME study will randomize 140 people assigned male sex at birth who use methamphetamine, are HIV-negative, and have recently engaged in an HIV sexual risk behavior to video directly observed therapy with contingency management (VDOT-CM) and counseling or counseling alone for 24 weeks. The primary aim of this study is to evaluate if VDOT-CM helps people who were assigned male sex at birth who use methamphetamine adhere to daily PrEP for HIV prevention. Participants will be assigned male sex at birth, age 18 years or older, who have used methamphetamine within the past 30 days, are HIV negative and interested in initiating PrEP, and report condomless sero-unknown/discordant sex in the past 12 months. Participants may also be individuals who recently started PrEP with an outside provider.

All subjects will complete the following study visits: screening, enrollment, follow-up visits 6, 12, and 18 weeks from enrollment, and a final follow-up visit at 24 weeks. At screening, enrollment, and all follow-up visits, laboratory testing for HIV, gonorrhea, chlamydia, and methamphetamine metabolites will be done. Syphilis and creatinine testing will be done at screening and week 24. Syphilis testing will also be done at enrollment and week 12. In addition, hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV) testing will be done at the screening visit. HCV testing will also be done at the week 24 visit.

At screening a medical history and physical exam will be performed; during enrollment and follow-up a symptom-directed exam will be performed at all visits, and under clinician discretion, a medical history and full exam will be done if needed. AEs will be assessed starting at enrollment and throughout follow-up. Vital signs and weight will be checked at all visits. Some lab procedures will vary if the participant receives PrEP from their own provider or is enrolled remotely.

At enrollment, participants will be randomized 1:1 to receiving only Integrated Next Step Counseling (iNSC) or iNSC and video directly-observed therapy (VDOT) with contingency management (CM). All participants will receive iNSC throughout their participation to support PrEP adherence and help their reduce risk for HIV. Dried blood spots (DBS) will be collected for FTC/TAF drug level testing at weeks 6, 12, 18, and 24. Participants randomized to the VDOT-CM arm will be asked to record taking their daily PrEP dose on VDOT every day from enrollment through week 24.

In-depth interviews will be conducted with at least 36 participants (18/arm) and participants who discontinue PrEP early or become infected with HIV during the study.

Eligibility criteria: 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.

Primary outcomes:
measure: Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
timeFrame: Week 6
measure: TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
timeFrame: Week 12
measure: TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
timeFrame: Week 18
measure: TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
timeFrame: Week 24
Secondary outcomes:
measure: Qualitative interview data describing participant experiences taking PrEP, with Integrated Next-Step Counseling, and among those randomized to the VDOT-CM arm, experience with VDOT-CM
timeFrame: Interviews done at end of study (24 weeks)
measure: SexPro score
timeFrame: Change in SexPro score from baseline at 12 weeks
measure: SexPro score
timeFrame: Change in SexPro score from baseline at 24 weeks
measure: ARCH-IDU Score
timeFrame: Change in ARCH-IDU score from baseline at 12 weeks
measure: ARCH-IDU Score
timeFrame: Change in ARCH-IDU score from baseline at 24 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Department of Public Health
state: California
Study officials:
affiliation: San Francisco Department of Public Health
name: Phillip Coffin
role: PRINCIPAL_INVESTIGATOR
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