Behavioral Therapy for Reducing HIV Risk

(IMPACT Trial)

Recruiting at 6 trial locations

Overseen By Erin Ricketts

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Westat

Disqualifiers: Severe illness, Non-English, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a behavioral program called IMPACT can reduce stimulant use and lower the risk of HIV transmission during sex. Researchers will divide participants into two groups: one will receive the IMPACT intervention, and the other will receive an enhanced standard of care (eSOC). The trial seeks individuals who have used stimulants like meth, cocaine, or MDMA during unprotected sex in the last four months. Participants must have a private space and internet access for online sessions. This study represents a step toward finding effective ways to lower HIV risks in those who use stimulants. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to innovative solutions for reducing HIV risks.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team for more details.

What prior data suggests that this behavioral intervention is safe for reducing HIV risk?

Research has shown that the IMPACT treatment helps individuals change their behavior to reduce risky sexual activities and stimulant use. Studies have found that participants in similar programs often reduce risky sexual behaviors, such as having sex without a condom. These programs typically include counseling sessions to improve sexual health and decision-making.

Regarding safety, no reports of negative effects have emerged from treatments like IMPACT, which primarily involve talking and guidance sessions. These sessions are generally easy for participants to handle, as they do not involve taking drugs or undergoing medical procedures, resulting in a lower risk of physical side effects. Participants in past studies have responded well to these sessions, demonstrating that this approach is safe for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Therapy for Reducing HIV Risk trial because it explores a unique approach to tackling HIV risk linked to stimulant use and condomless sex. Unlike traditional treatments that often focus on medication, this trial examines the IMPACT intervention, which combines behavioral therapy with risk reduction strategies. This method aims to directly address the behavioral aspect of risk, offering a potentially more holistic solution. By understanding and altering behavior patterns, the trial hopes to provide a new avenue for reducing HIV transmission rates, especially among those who might not benefit fully from existing medical treatments.

What evidence suggests that this trial's treatments could be effective for reducing HIV risk?

Research has shown that certain programs can help reduce behaviors that increase the risk of HIV. In this trial, participants will be randomized into different groups to evaluate the effectiveness of these programs. The IMPACT approach, one of the interventions in this trial, often includes counseling and support to promote safer sex practices, such as using condoms. A review found that one-on-one support can help people change risky sexual behaviors, potentially lowering their HIV risk. Additionally, using stimulants is linked to more unprotected sex, but specific strategies can help reduce these risks. Early findings suggest that these methods, including the IMPACT program, may significantly lower the risk of HIV transmission. Another group in this trial will receive Enhanced Standard of Care (eSOC), which serves as an active comparator to assess the relative effectiveness of the IMPACT intervention. ^{1 3 6 7 8}

Who Is on the Research Team?

Katie Biello, PhD, MPH

Principal Investigator

Brown University

Matthew Mimiaga, ScD, MPH

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for young gay/bisexual minority men who are sexually active. It's designed to help those who use stimulants and may be at risk of HIV transmission. Specific eligibility details aren't provided, but typically participants must meet certain health and demographic criteria.

Inclusion Criteria

Virtual participants must also have access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)

Virtual participants must also reside within the continental U.S.

Willing and able to provide written informed consent for study participation

Exclusion Criteria

Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable)

Non-English-speaking

Is currently incarcerated or pending incarceration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the IMPACT group receive 10 sessions over approximately 10 weeks, including HIV risk reduction, behavioral activation, and relapse prevention

10 weeks

10 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with reports on CAS and stimulant use at specified intervals

12 months

4 visits (in-person or virtual) at Baseline, Month 4, Month 8, and Month 12

What Are the Treatments Tested in This Trial?

Interventions

• eSOC
• IMPACT

Trial Overview The trial is testing a behavioral intervention called IMPACT, compared with an electronic Social Networking (eSOC) strategy, to see if they can reduce stimulant use and lower the risk of HIV among participants.

How Is the Trial Designed?

Group I: IMPACT Group Experimental Treatment 1 Intervention

Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention.

Group II: Enhanced Standard of Care (eSOC) Group Active Control 1 Intervention

Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention.

Who Is Running the Clinical Trial?

Westat

Lead Sponsor

Trials

49

Recruited

39,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Behavioral medicine interventions can significantly improve the quality of life for individuals with HIV by addressing related issues such as nutritional disorders, pain management, sleep disorders, and treatment adherence.

As the number of people living with HIV increases and their life expectancy extends due to medical advancements, there is an urgent need to implement these behavioral approaches to enhance health outcomes and alleviate the effects of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral medicine interventions can improve the quality-of-life and health of persons with HIV disease. Sikkema, KJ., Kelly, JA.[2021]

A group-based cognitive behavioral stress management (CBSM) intervention for HIV-positive men significantly reduces psychological distress and improves immune function, highlighting its potential as an effective psychosocial treatment.

Both poor HIV+ African American women and affluent gay men benefit from CBSM, but treatment protocols must consider gender and sociocultural differences to be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral medicine and the management of HIV/AIDS. Schneiderman, N.[2018]

In Romania, despite universal access to HIV care, medication adherence to antiretroviral treatment (ART) is low, highlighting the need for improved support services, as revealed through interviews with 10 practitioners from six HIV centers.

Practitioners primarily use interview-based assessments and psychotherapeutic techniques to support adherence, but they face challenges such as limited resources and a lack of structured behavioral theory application, indicating opportunities for standardizing and enhancing adherence support interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where we are now and how we can improve: a qualitative study of practitioners' perspectives on providing ART adherence support in Romania. Dima, AL., Linn, AJ., Schweitzer, AM.[2018]

Recent behavioral research has significantly improved strategies for preventing HIV infections, demonstrating effective risk-reduction interventions at individual, couple, group, community, and policy levels.

Advancements in HIV medical care have introduced new challenges for behavioral scientists, highlighting the need for ongoing research in secondary prevention to address the needs of those living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral research in HIV/AIDS primary and secondary prevention: recent advances and future directions. Kelly, JA., Kalichman, SC.[2022]

Behavioral interventions to reduce the risk of HIV infection are effective and should be widely implemented, as supported by a consensus of experts from various fields who reviewed scientific evidence.

Legislative barriers, such as restrictions on needle exchange programs and funding cuts for drug abuse treatment, must be removed to enhance the effectiveness of these interventions and protect at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent HIV risk behaviors. National Institutes of Health Consensus Development Conference Statement February 11-13, 1997. [2004]

There is a critical need for more systematic research on intervention outcomes related to both HIV prevention and mental health support, as current studies have primarily focused on risk reduction and have not fully addressed emotional coping needs.

Future progress in HIV intervention strategies can be enhanced by linking them to behavioral theories, identifying effective elements for behavior change, and focusing on at-risk populations, including gay men and injection drug users, as well as urban and minority groups facing increased threats from HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions with AIDS and HIV: prevention and treatment. Kelly, JA., Murphy, DA.[2019]

Behavioral interventions to reduce the risk of HIV infection are effective and should be widely implemented, as supported by a comprehensive review of scientific evidence presented by a panel of experts.

Legislative barriers, such as restrictions on needle exchange programs and funding cuts for drug abuse treatment, must be removed to enhance the effectiveness of HIV prevention strategies and protect vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent HIV risk behaviors. [2015]

Addressing psychosocial stressors such as treatment adherence, depression, high-risk sexual behavior, and substance abuse can significantly improve the quality of life and treatment outcomes for individuals living with HIV.

Regular contact with healthcare providers presents a valuable opportunity to assess and intervene on these behavioral aspects, potentially leading to decreased HIV transmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral aspects of HIV care: adherence, depression, substance use, and HIV-transmission behaviors. Berg, CJ., Michelson, SE., Safren, SA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5729925/

Efficacy of Behavioral Interventions to Increase Condom ... Condoms were provided in 39% of the interventions. Most interventions (94%) included counseling and testing. Boosters were provided in 46% of the interventions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06444360

Behavioral Activation and Risk Reduction for Stimulant Use ... This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT for translation into real-world practice using a hybrid ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379706005551

The Effectiveness of Individual-, Group ... This review assesses the overall effectiveness of person-to-person HIV behavioral interventions designed to promote change in sex behaviors (e.g., increase ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4296895/

Stimulant use patterns and HIV transmission risk among ... Stimulant use is associated with increased condomless anal intercourse (CAI), alcohol abuse, and drug use with primary and outside partners.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-018-5856-0

A randomized controlled efficacy trial of behavioral activation ... The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30045702/

A randomized controlled efficacy trial of behavioral activation ... In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.

7. link.springer.com link.springer.com/article/10.1007/s10461-021-03181-4

A Systematic Review and Meta-analysis, 2010–2020 Overall, participants in the intervention group reduced sexual risk or condomless sex relative to control groups. The effect was higher for ...

8. iasusa.org iasusa.org/wp-content/uploads/2024/12/32-5-571.pdf

Managing Stimulant Use Among People With HIV 21 This program focuses on improving sexual health while reducing or stopping stimulant use, promoting behaviors that reduce the risk of HIV.