Behavioral Therapy for Reducing HIV Risk

(IMPACT Trial)

Recruiting at 6 trial locations

Overseen By Erin Ricketts

Age: < 65

Sex: Male

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

Trial Summary

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 data supports the effectiveness of the treatment eSOC, IMPACT for reducing HIV risk?

Research shows that behavioral therapy, like the eSOC, IMPACT treatment, can help people with HIV by improving their medication adherence and reducing risky behaviors, which are crucial for managing the disease and preventing its spread. Studies have found that group-based cognitive behavioral stress management can decrease distress and improve health outcomes in HIV patients, suggesting that similar behavioral interventions could be effective in reducing HIV risk. ^{1 2 3 4 5}

How is the IMPACT treatment different from other HIV risk reduction treatments?

The IMPACT treatment is unique because it focuses on behavioral therapy to reduce HIV risk, emphasizing individual and group interventions to change risk behaviors, unlike traditional medical treatments that primarily focus on medication. ^{1 2 6 7 8}

What is the purpose of this trial?

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk

Research Team

Katie Biello, PhD, MPH

Principal Investigator

Brown University

Matthew Mimiaga, ScD, MPH

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: IMPACT Group Experimental Treatment 1 Intervention

A multifaceted training and implementation strategy across sites and formats will be used. Participants who report stimulant use in the context of condomless anal sex (CAS), will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. The participants in this arm participate in 10 sessions (approximately 50 minutes each) delivered over the course of approximately 10 weeks.

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

The comparison arm will receive the same 2 HIV sexual risk reduction (RR) intervention sessions and referrals to substance use and mental health treatment, per SOC.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral aspects of HIV care: adherence, depression, substance use, and HIV-transmission behaviors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Psychological interventions with AIDS and HIV: prevention and treatment. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral research in HIV/AIDS primary and secondary prevention: recent advances and future directions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Interventions to prevent HIV risk behaviors. [2015]