HIV InfectionsPhase 4PRIMENCT04523519
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
A Phase 4 study testing Video directly observed therapy with contingency management and Integrated Next-Step Counseling in people with HIV Infections, run by San Francisco Department of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Video directly observed therapy with contingency management and Integrated Next-Step Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 22 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 methamphetamine use on 4 or more days, by self-report,
- ≥ 1 positive methamphetamine urine toxicology,
- 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),
Show all 10Show fewer
- Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months,
- HIV-negative,
- Reliable access to a computer to complete study visits, if participating remotely, AND
- Proficient in English
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- On PrEP for more than 6 months,
- Unwillingness to use a video app to record oneself taking PrEP, OR
- 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:
- Contraindication to tenofovir or emtricitabine-containing products,
- Creatinine clearance ≤30 mL/min, OR
- Positive hepatitis B surface antigen test.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Video directly observed therapy with contingency management, Integrated Next-Step Counseling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video directly observed therapy with contingency managementBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video directly observed therapy with contingency management | Experimental | Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling. Receives: Behavioral: Video directly observed therapy with contingency management; Behavioral: Integrated Next-Step Counseling |
| Integrated Next-Step Counseling | Placebo comparator | Not described Receives: Behavioral: Integrated Next-Step Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
Measured: Week 6
TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
Measured: Week 12
TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
Measured: Week 18
TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots
Measured: Week 24
Secondary outcomes (5)
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
Measured: Interviews done at end of study (24 weeks)
SexPro score
Score that measures sexual HIV risk
Measured: Change in SexPro score from baseline at 12 weeks
SexPro score
Score that measures sexual HIV risk
Measured: Change in SexPro score from baseline at 24 weeks
ARCH-IDU Score
Score that measures HIV risk related to injection drug use
Measured: Change in ARCH-IDU score from baseline at 12 weeks
ARCH-IDU Score
Score that measures HIV risk related to injection drug use
Measured: Change in ARCH-IDU score from baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Apr 2021
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Phillip Coffin, Principal investigator, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523519
- Sponsor's protocol ID
- R01DA051850
- Other IDs
- R01DA051850
- Acronym
- PRIME
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published 2018. Accessed November 1, 2019
San Francisco Department of Public Health. HIV Epidemiology Annual Report 2018. San Francisco Department of Public Health. https://www.sfdph.org/dph/files/reports/RptsHIVAIDS/HIV-Epidemiology-Annual-Report2018.pdf. Published 2019. Accessed November 4, 2019.
Degenhardt L, Mathers B, Guarinieri M, Panda S, Phillips B, Strathdee SA, Tyndall M, Wiessing L, Wodak A, Howard J; Reference Group to the United Nations on HIV and injecting drug use. Meth/amphetamine use and associated HIV: Implications for global policy and public health. Int J Drug Policy. 2010 Sep;21(5):347-58. doi: 10.1016/j.drugpo.2009.11.007. Epub 2010 Feb 1.
PubMed 20117923HIV/AIDS Epidemiology Unit, Public Health - Seattle & King County and the Infectious Disease Assessment Unit, Washington State Department of Health. HIV/AIDS Epidemiology Report & Community Profile 2019, Volume 88.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PubMed 21091279Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
PubMed 23769234Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Curlin ME, Na-Pompet S, Warapronmongkholkul A, Kittimunkong S, Gvetadze RJ, McNicholl JM, Paxton LA, Choopanya K; Bangkok Tenofovir Study Group. The impact of adherence to preexposure prophylaxis on the risk of HIV infection among people who inject drugs. AIDS. 2015 Apr 24;29(7):819-24. doi: 10.1097/QAD.0000000000000613.
PubMed 25985403Storholm ED, Volk JE, Marcus JL, Silverberg MJ, Satre DD. Risk Perception, Sexual Behaviors, and PrEP Adherence Among Substance-Using Men Who Have Sex with Men: a Qualitative Study. Prev Sci. 2017 Aug;18(6):737-747. doi: 10.1007/s11121-017-0799-8.
PubMed 28578516Finlayson T, Cha S, Xia M, Trujillo L, Denson D, Prejean J, Kanny D, Wejnert C; National HIV Behavioral Surveillance Study Group. Changes in HIV Preexposure Prophylaxis Awareness and Use Among Men Who Have Sex with Men - 20 Urban Areas, 2014 and 2017. MMWR Morb Mortal Wkly Rep. 2019 Jul 12;68(27):597-603. doi: 10.15585/mmwr.mm6827a1.
PubMed 31298662Chen YH, Guigayoma J, McFarland W, Snowden JM, Raymond HF. Increases in Pre-exposure Prophylaxis Use and Decreases in Condom Use: Behavioral Patterns Among HIV-Negative San Francisco Men Who have Sex with Men, 2004-2017. AIDS Behav. 2019 Jul;23(7):1841-1845. doi: 10.1007/s10461-018-2299-7.
PubMed 30306436McMahan VM, Pope E, Luna Marti X, Walker J, Liu AY, Coffin PO. Interest in Long-Acting Preexposure Prophylaxis (PrEP) Among Men at Risk for Human Immunodeficiency Virus Who Use Methamphetamine Participating in a Daily, Oral PrEP Adherence Trial in San Francisco, California. Open Forum Infect Dis. 2025 May 12;12(5):ofaf280. doi: 10.1093/ofid/ofaf280. eCollection 2025 May.
PubMed 40406373
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP Intervention for People Who Inject Substances and Use Methamphetamine
- ClinicalTrials.gov ID
- NCT04523519
- Acronym / sponsor ID
- PRIME / R01DA051850
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video directly observed therapy with contingency management | Experimental | Behavioral: Video directly observed therapy with contingency management, Behavioral: Integrated Next-Step CounselingVideo directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling. |
| Integrated Next-Step Counseling | Placebo comparator | Behavioral: Integrated Next-Step Counseling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 methamphetamine use on 4 or more days, by self-report,
- ≥ 1 positive methamphetamine urine toxicology,
Key exclusion criteria (8 listed)
- On PrEP for more than 6 months,
- Unwillingness to use a video app to record oneself taking PrEP, OR
- 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:
- Contraindication to tenofovir or emtricitabine-containing products,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video directly observed therapy with contingency managementPrEP 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. | Behavioural | Video directly observed therapy with contingency management |
| Integrated Next-Step CounselingIntegrated 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. | Behavioural | Integrated Next-Step Counseling, Video directly observed therapy with contingency management |
Primary outcome
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
5 secondary outcomes
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
SexPro score
Time frame: Change in SexPro score from baseline at 24 weeks
ARCH-IDU Score
Time frame: Change in ARCH-IDU score from baseline at 12 weeks
ARCH-IDU Score
Time frame: Change in ARCH-IDU score from baseline at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- BackgroundCenters for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published 2018. Accessed November 1, 2019
- BackgroundSan Francisco Department of Public Health. HIV Epidemiology Annual Report 2018. San Francisco Department of Public Health. https://www.sfdph.org/dph/files/reports/RptsHIVAIDS/HIV-Epidemiology-Annual-Report2018.pdf. Published 2019. Accessed November 4, 2019.
- Background: PubMed 20117923Degenhardt L, Mathers B, Guarinieri M, Panda S, Phillips B, Strathdee SA, Tyndall M, Wiessing L, Wodak A, Howard J; Reference Group to the United Nations on HIV and injecting drug use. Meth/amphetamine use and associated HIV: Implications for global policy and public health. Int J Drug Policy. 2010 Sep;21(5):347-58. doi: 10.1016/j.drugpo.2009.11.007. Epub 2010 Feb 1.
- BackgroundHIV/AIDS Epidemiology Unit, Public Health - Seattle & King County and the Infectious Disease Assessment Unit, Washington State Department of Health. HIV/AIDS Epidemiology Report & Community Profile 2019, Volume 88.
- Background: PubMed 21091279Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
- Background: PubMed 23769234Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
- Background: PubMed 25985403Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Curlin ME, Na-Pompet S, Warapronmongkholkul A, Kittimunkong S, Gvetadze RJ, McNicholl JM, Paxton LA, Choopanya K; Bangkok Tenofovir Study Group. The impact of adherence to preexposure prophylaxis on the risk of HIV infection among people who inject drugs. AIDS. 2015 Apr 24;29(7):819-24. doi: 10.1097/QAD.0000000000000613.
- Background: PubMed 28578516Storholm ED, Volk JE, Marcus JL, Silverberg MJ, Satre DD. Risk Perception, Sexual Behaviors, and PrEP Adherence Among Substance-Using Men Who Have Sex with Men: a Qualitative Study. Prev Sci. 2017 Aug;18(6):737-747. doi: 10.1007/s11121-017-0799-8.
- Background: PubMed 31298662Finlayson T, Cha S, Xia M, Trujillo L, Denson D, Prejean J, Kanny D, Wejnert C; National HIV Behavioral Surveillance Study Group. Changes in HIV Preexposure Prophylaxis Awareness and Use Among Men Who Have Sex with Men - 20 Urban Areas, 2014 and 2017. MMWR Morb Mortal Wkly Rep. 2019 Jul 12;68(27):597-603. doi: 10.15585/mmwr.mm6827a1.
- Background: PubMed 30306436Chen YH, Guigayoma J, McFarland W, Snowden JM, Raymond HF. Increases in Pre-exposure Prophylaxis Use and Decreases in Condom Use: Behavioral Patterns Among HIV-Negative San Francisco Men Who have Sex with Men, 2004-2017. AIDS Behav. 2019 Jul;23(7):1841-1845. doi: 10.1007/s10461-018-2299-7.
- Derived from this study: PubMed 40406373McMahan VM, Pope E, Luna Marti X, Walker J, Liu AY, Coffin PO. Interest in Long-Acting Preexposure Prophylaxis (PrEP) Among Men at Risk for Human Immunodeficiency Virus Who Use Methamphetamine Participating in a Daily, Oral PrEP Adherence Trial in San Francisco, California. Open Forum Infect Dis. 2025 May 12;12(5):ofaf280. doi: 10.1093/ofid/ofaf280. eCollection 2025 May.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Coffin principal investigator
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Video directly observed therapy with contingency management and Integrated Next-Step Counseling in people with HIV Infections, run by San Francisco Department of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots (time frame: Week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04523519, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.