PrEP Intervention for People Who Inject Substances and Use Methamphetamine (PRIME)
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| ClinicalTrials.gov Identifier: NCT04523519 |
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Recruitment Status :
Recruiting
First Posted : August 21, 2020
Last Update Posted : October 6, 2021
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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 cisgender men who have sex with men (MSM) who inject methamphetamine adhere to FTC/TAF (Descovy) PrEP. We will randomize 140 adults who inject substances and 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 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 or sexual risk behaviors for HIV among study participants after they begin taking PrEP.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Behavioral: Video directly observed therapy with contingency management Behavioral: Integrated Next-Step Counseling | Phase 4 |
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 MSM who inject substances and 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 MSM who inject substances and use methamphetamine adhere to daily PrEP for HIV prevention. Participants will be MSM, age 18 years or older, who have injected substances and used methamphetamine within the past 30 days, are HIV negative and interested in initiating PrEP, and report condomless sero-unknown/discordant sex with a man in the past 12 months.
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, week 12, and week 24. Syphilis testing will also be done at enrollment. In addition, hepatitis B surface antibody (HBsAb) and 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.
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | PrEP Intervention for People Who Inject Substances and Use Methamphetamine |
| Actual Study Start Date : | April 30, 2021 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | May 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Video directly observed therapy with contingency management
Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling.
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Behavioral: 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. Behavioral: 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. |
| Placebo Comparator: Integrated Next-Step Counseling |
Behavioral: 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. |
- Tenofovir diphosphate (TFV-DP) levels >= 950 fmol/punch in dried blood spots [ Time Frame: Week 6 ]
- TFV-DP levels >= 950 fmol/punch in dried blood spots [ Time Frame: Week 12 ]
- TFV-DP levels >= 950 fmol/punch in dried blood spots [ Time Frame: Week 18 ]
- TFV-DP levels >= 950 fmol/punch in dried blood spots [ Time Frame: Week 24 ]
- 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 [ Time Frame: Interviews done at end of study (24 weeks) ]
- SexPro score [ Time Frame: Change in SexPro score from baseline at 12 weeks ]Score that measures sexual HIV risk
- SexPro score [ Time Frame: Change in SexPro score from baseline at 24 weeks ]Score that measures sexual HIV risk
- ARCH-IDU Score [ Time Frame: Change in ARCH-IDU score from baseline at 12 weeks ]Score that measures HIV risk related to injection drug use
- ARCH-IDU Score [ Time Frame: Change in ARCH-IDU score from baseline at 24 weeks ]Score that measures HIV risk related to injection drug use
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Age 18-65 years inclusive,
- Assigned male sex at birth,
- Past 30-day injection of substances, by self-report,
- Past 30-day methamphetamine use on 4 or more days, by self-report,
- ≥ 1 positive methamphetamine urine toxicology,
- Interested in initiating PrEP,
- Reports condomless sero-unknown/discordant anal sex with a man in the past 12 months,
- HIV-negative,
- Willing to use an app to video record themselves taking PrEP as part of study participation, AND
- Proficient in English
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- On FTC/TDF PrEP in prior 90 days (3 months) if initiating FTC/TAF PrEP, or on FTC/TDF PrEP in prior 42 days (6 weeks) if initiating FTC/TDF PrEP, OR on FTC/TAF PrEP in prior 42 days (6 weeks), or enrolled in another PrEP study,
- Unwillingness to use a video app to record oneself taking PrEP, OR
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Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.
In addition, participants must meet the clinical criteria for taking PrEP to participate in the PRIME study. For participants who receive PrEP at an outside provider, we will defer to the outside provider for dispensation eligibility and will not assess the below criteria.
For participants receiving PrEP from the study team, exclusion criteria will be the following:
- Contraindication to tenofovir or emtricitabine-containing products,
- Creatinine clearance ≤30 mL/min, OR
- Chronic hepatitis B infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523519
| Contact: Phillip Coffin, MD | 628-217-6282 | phillip.coffin@sfdph.org | |
| Contact: Vanessa McMahan, PhD | 628-217-7469 | vanessa.mcmahan@sfdph.org |
| United States, California | |
| San Francisco Department of Public Health | Recruiting |
| San Francisco, California, United States, 94102 | |
| Contact: Phillip Coffin, MD 628-217-6282 phillip.coffin@sfdph.org | |
| Contact: Vanessa McMahan, PhD 628-217-7469 vanessa.mcmahan@sfdph.org | |
| Principal Investigator: | Phillip Coffin | San Francisco Department of Public Health |
| Responsible Party: | Phillip Coffin, MD, MIA, Director of Substance Use Research, San Francisco Department of Public Health |
| ClinicalTrials.gov Identifier: | NCT04523519 |
| Other Study ID Numbers: |
R01DA051850 ( U.S. NIH Grant/Contract ) R01DA051850 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 21, 2020 Key Record Dates |
| Last Update Posted: | October 6, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |