Drug Use DisordersNCT07281378
Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
A study testing Tailored Positive Affect Intervention and Contingency Management in people with Drug Use Disorders and PrEP Uptake, run by University of Florida.
Trial summary
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Use Disorders, PrEP Uptake, PrEP Adherence
- What is being tested?
- Tailored Positive Affect Intervention and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years of age or older;
- be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
- report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
- have HIV-negative serostatus;
- be bilingual (Spanish and English), or Spanish or English monolingual;
- meet CDC criteria for PrEP eligibility.
Who cannot join
- display diminished capacity to consent (e.g., cognitive impairment); or
- severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
- if they are HIV positive or living with HIV;
- if they are already taking PrEP; and
- if the participant can't consent to participate in English or Spanish.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
- Conditions
- Drug Use Disorders, PrEP Uptake, PrEP Adherence, HIV Risk Behavior
- Being tested
- Tailored Positive Affect Intervention, Contingency Management
- Keywords
- PrEP, PrEP uptake, HIV, substance use, stimulant use, men at high risk for HIV
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Positive Affect InterventionBehavioural
The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T
The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory.
Contingency ManagementBehavioural
Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP.
| Study group | Role | What they receive |
|---|---|---|
| Attention-Control condition | Other | Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises. Receives: Behavioral: Contingency Management |
| Experimental condition | Experimental | Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. Receives: Behavioral: Tailored Positive Affect Intervention; Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PrEP uptake
Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP.
Measured: From enrollment to 6 months
Secondary outcomes (3)
Stimulant use (self-report)
Changes in the severity of participant stimulant use as measured by the Alcohol, Smoking, and Substance Involvement Screen Test (ASSIST) composite scores for cocaine and amphetamine-type stimulants.
Measured: Enrollment to 6 months
Condomless Anal Sex (CAS)
Changes in the number of CAS partners who are not taking PrEP or virally suppressed.
Measured: From enrollment to 6 months
Social Network Composition
Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP.
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start13 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Drug Use DisordersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jose Colon-Burgos, DrPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281378
- Sponsor's protocol ID
- IRB202501242
- Other IDs
- 5R00DA053158-05
- Status last verified
- Oct 2025
- First submitted
- 11 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets from the study will be shared.
Publications
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, New Jersey: Lawrence Earlbaum Associates; 1988.
Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.
PubMed 12365874Molenberghs G, Verbeke G. Models for Discrete Longituidnal Data. New York: Springer- Verlag; 2005.
Reback CJ, Peck JA, Dierst-Davies R, Nuno M, Kamien JB, Amass L. Contingency management among homeless, out-of-treatment men who have sex with men. J Subst Abuse Treat. 2010 Oct;39(3):255-63. doi: 10.1016/j.jsat.2010.06.007. Epub 2010 Jul 29.
PubMed 20667681Shoptaw S, Reback CJ, Peck JA, Yang X, Rotheram-Fuller E, Larkins S, Veniegas RC, Freese TE, Hucks-Ortiz C. Behavioral treatment approaches for methamphetamine dependence and HIV-related sexual risk behaviors among urban gay and bisexual men. Drug Alcohol Depend. 2005 May 9;78(2):125-34. doi: 10.1016/j.drugalcdep.2004.10.004. Epub 2004 Nov 28.
PubMed 15845315Shoptaw S, Klausner JD, Reback CJ, Tierney S, Stansell J, Hare CB, Gibson S, Siever M, King WD, Kao U, Dang J. A public health response to the methamphetamine epidemic: the implementation of contingency management to treat methamphetamine dependence. BMC Public Health. 2006 Aug 18;6:214. doi: 10.1186/1471-2458-6-214.
PubMed 16919170Saldaña J. The Coding Manual for Qualitative Researchers. 3rd ed. Los Angeles, CA: SAGE; 2016.
Creswell JW. Qualitative Inquiry and Research Design: Choosing among Five Approaches. 3ed ed. Thousand Oaks,California: SAGE Publications; 2013.
Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Clinical Practice Guideline.; 2018. https://www.cdc.gov/std/tg2015/tg-2015-.
Mccarty C, Lubbers MJ, Vacca R, Molina JL. Conducting Personal Network Research: A Practical Guide. New York, N.Y.: The Guilford Press; 2019. www.guilford.com.
27855594
Padilla M, Colon-Burgos JF, Varas-Diaz N, Matiz-Reyes A, Parker CM. Tourism Labor, Embodied Suffering, and the Deportation Regime in the Dominican Republic. Med Anthropol Q. 2018 Dec;32(4):498-519. doi: 10.1111/maq.12447. Epub 2018 May 8.
PubMed 29665064Colon Burgos JF, Padilla M, Nunez A, Varas-Diaz N, Matiz-Reyes A. An ethnographic study of 'touristic escapism' and health vulnerability among Dominican male tourism workers. Glob Public Health. 2019 Nov;14(11):1578-1588. doi: 10.1080/17441692.2019.1651370. Epub 2019 Aug 9.
PubMed 31397201Carrico AW, Zepf R, Meanley S, Batchelder A, Stall R. Critical Review: When the Party is Over: A Systematic Review of Behavioral Interventions for Substance-Using Men Who Have Sex with Men. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):299-306. doi: 10.1097/QAI.0000000000001102.
PubMed 27258233Folkman S. The case for positive emotions in the stress process. Anxiety Stress Coping. 2008 Jan;21(1):3-14. doi: 10.1080/10615800701740457.
PubMed 18027121
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
- ClinicalTrials.gov ID
- NCT07281378
- Acronym / sponsor ID
- IRB202501242
- Conditions
- Drug Use Disorders, PrEP Uptake, PrEP Adherence, HIV Risk Behavior
- Keywords
- PrEP, PrEP uptake, HIV, substance use, stimulant use, men at high risk for HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Dec 2025 (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.
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention-Control condition | Other | Behavioral: Contingency ManagementParticipants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises. |
| Experimental condition | Experimental | Behavioral: Tailored Positive Affect Intervention, Behavioral: Contingency ManagementParticipants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age or older;
- be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
- report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
- have HIV-negative serostatus;
- be bilingual (Spanish and English), or Spanish or English monolingual;
Key exclusion criteria (5 listed)
- display diminished capacity to consent (e.g., cognitive impairment); or
- severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
- if they are HIV positive or living with HIV;
- if they are already taking PrEP; and
- if the participant can't consent to participate in English or Spanish.
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 |
|---|---|---|
| Tailored Positive Affect InterventionThe intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. | Behavioural | Experimental condition |
| Contingency ManagementIncentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. | Behavioural | Attention-Control condition, Experimental condition |
Primary outcome
Rate of PrEP uptake
Time frame: From enrollment to 6 months
Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP.
3 secondary outcomes
Stimulant use (self-report)
Time frame: Enrollment to 6 months
Condomless Anal Sex (CAS)
Time frame: From enrollment to 6 months
Social Network Composition
Time frame: From enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- BackgroundCohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, New Jersey: Lawrence Earlbaum Associates; 1988.
- Background: PubMed 12365874Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.
- BackgroundMolenberghs G, Verbeke G. Models for Discrete Longituidnal Data. New York: Springer- Verlag; 2005.
- Background: PubMed 20667681Reback CJ, Peck JA, Dierst-Davies R, Nuno M, Kamien JB, Amass L. Contingency management among homeless, out-of-treatment men who have sex with men. J Subst Abuse Treat. 2010 Oct;39(3):255-63. doi: 10.1016/j.jsat.2010.06.007. Epub 2010 Jul 29.
- Background: PubMed 15845315Shoptaw S, Reback CJ, Peck JA, Yang X, Rotheram-Fuller E, Larkins S, Veniegas RC, Freese TE, Hucks-Ortiz C. Behavioral treatment approaches for methamphetamine dependence and HIV-related sexual risk behaviors among urban gay and bisexual men. Drug Alcohol Depend. 2005 May 9;78(2):125-34. doi: 10.1016/j.drugalcdep.2004.10.004. Epub 2004 Nov 28.
- Background: PubMed 16919170Shoptaw S, Klausner JD, Reback CJ, Tierney S, Stansell J, Hare CB, Gibson S, Siever M, King WD, Kao U, Dang J. A public health response to the methamphetamine epidemic: the implementation of contingency management to treat methamphetamine dependence. BMC Public Health. 2006 Aug 18;6:214. doi: 10.1186/1471-2458-6-214.
- BackgroundSaldaña J. The Coding Manual for Qualitative Researchers. 3rd ed. Los Angeles, CA: SAGE; 2016.
- BackgroundCreswell JW. Qualitative Inquiry and Research Design: Choosing among Five Approaches. 3ed ed. Thousand Oaks,California: SAGE Publications; 2013.
- BackgroundCenters for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Clinical Practice Guideline.; 2018. https://www.cdc.gov/std/tg2015/tg-2015-.
- BackgroundMccarty C, Lubbers MJ, Vacca R, Molina JL. Conducting Personal Network Research: A Practical Guide. New York, N.Y.: The Guilford Press; 2019. www.guilford.com.
- Background27855594
- Background: PubMed 29665064Padilla M, Colon-Burgos JF, Varas-Diaz N, Matiz-Reyes A, Parker CM. Tourism Labor, Embodied Suffering, and the Deportation Regime in the Dominican Republic. Med Anthropol Q. 2018 Dec;32(4):498-519. doi: 10.1111/maq.12447. Epub 2018 May 8.
- Individual participant dataSharing planned: Yes. De-identified datasets from the study will be shared.
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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.
Jose Colon-Burgos, DrPH principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Positive Affect Intervention and Contingency Management in people with Drug Use Disorders and PrEP Uptake, run by University of Florida.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Colon-Burgos, DrPH ((352) 273-9188, jcolonburgos@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PrEP uptake (time frame: From enrollment to 6 months). 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 NCT07281378, which also lists 50 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 29 Sep 2026.