Challenges with engaging participants in behavioral intervention research trials

David Olem, Kelly M Sharp, Mallory O JohnsonDepartment of Medicine, University of California, San Francisco, CA, USAAbstract: In clinical trials research, nonadherence to an investigational health promotion intervention poses threats to internal validity, thus raising concern over the trial outcomes and interpretation of results. Successfully helping participants to engage in and complete a multisession intervention can be particularly challenging. This task can become more complicated when working with participants who are dealing with chronic health conditions and are from diverse cultural, socio-economic, and marginalized backgrounds who may have competing needs, beliefs, and priorities that conflict with the needs of the trial protocols. This paper identifies some of the challenges to helping individuals participate in the sessions of a behavioral intervention and shares a set of strategies developed by a clinical research team to engage with participants and minimize barriers to completing the intervention.Keywords: clinical trials, behavioral interventions, retention, internal validit

Overcoming Barriers to HIV Treatment Adherence: A Brief Cognitive Behavioral Intervention for HIV-Positive Adults on Antiretroviral Treatment

Maximizing HIV treatment adherence is critical in efforts to optimize health outcomes and to prevent further HIV transmission. The Balance Project intervention uses cognitive behavioral approaches to improve antiretroviral medication adherence through promoting adaptive coping with medication side effect and distress related to HIV. This 5-session intervention has been documented to prevent nonadherence among persons living with HIV who experience high levels of distress associated with their antiretroviral medication side effects. We describe the theoretical underpinnings of the intervention, provide details of the training and session protocols with a case example, and discuss implications for future applications of the intervention in both research and clinical settings

Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial

Introduction Advances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysis This paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and dissemination All procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration number NCT02925949; Pre-results

Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial.

IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results

Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial.

IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results

Optimizing Contingency Management with Methamphetamine-Using Men who Have Sex with Men

Among men who have sex with men (MSM), methamphetamine use is associated with multiple, overlapping syndemic conditions including increased risk for HIV seroconversion and onward HIV transmission. Contingency management (CM) is an evidence-based, behavioral intervention implemented to curb methamphetamine use and optimize HIV/AIDS prevention among MSM in San Francisco since 2003. We conducted a program evaluation to document the evolution of this 12-week CM program to include delivery of brief, individual counseling incorporating motivational interviewing and behavioral skills. A drop-in group delivered concurrently with CM urine-screening visits also provides peer support as well as referrals for other social and medical services. From December 2011-October 2013, a total of 131 clients enrolled in the CM program and provided a median of 22 urine samples (Interquartile Range = 10–34) that were non-reactive for methamphetamine. Findings support the feasibility and acceptability of integrating individual and group counseling with community-based CM for methamphetamine-using MSM

Finding Sunshine on a Cloudy Day: A Positive Affect Intervention for Co-Occurring Methamphetamine Use and HIV

•Describes a novel positive affect intervention to improve long-term outcomes.•Details the theoretical underpinnings of the positive affect intervention.•Provides a case study example of how the positive affect intervention is tailored.•Underscores the complex care needs of sexual minority men who use methamphetamine. Among sexual minority men (i.e., gay, bisexual, and other men who have sex with men) living with HIV, those who use methamphetamine experience profound health disparities. Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS) is an evidence-based, 5-session, individually delivered positive affect intervention adapted for sexual minority men living with HIV who use methamphetamine. ARTEMIS was designed to amplify the benefits of evidence-based substance use interventions such as contingency management (CM) with this high-priority population. Delivering ARTEMIS during CM has been shown to assist participants in reducing stimulant use, increasing positive affect, and achieving durable reductions in HIV viral load. We describe the theoretical underpinnings of the ARTEMIS intervention, provide details of the training and session protocols with a case example, and discuss implications for future applications in research and clinical settings

Optimizing Contingency Management With Methamphetamine-Using Men Who Have Sex With Men

Among men who have sex with men (MSM), methamphetamine use is associated with multiple, overlapping syndemic conditions including increased risk for HIV seroconversion and onward HIV transmission. Contingency management (CM) is an evidence-based behavioral intervention implemented to curb methamphetamine use and optimize HIV/AIDS prevention among MSM in San Francisco since 2003. We conducted a program evaluation to document the evolution of this 12-week CM program to include delivery of brief, individual counseling incorporating motivational interviewing and behavioral skills. A drop-in group delivered concurrently with CM urine-screening visits also provides peer support as well as referrals for other social and medical services. From December 2011–October 2013, a total of 131 clients enrolled in the CM program and provided a median of 22 urine samples (Interquartile Range = 10–34) that were nonreactive for methamphetamine. Findings support the feasibility and acceptability of integrating individual and group counseling with community-based CM for methamphetamine-using MSM

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men.

BackgroundContingency management (CM) is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts.Methods/designThis randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM) is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention - Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior.DiscussionImplementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018.Trial registrationThis trial was registered on clinicaltrials.gov ( NCT01926184 ) on August 16, 2013