scholarly journals Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jason William Mitchell ◽  
Ji-Young Lee ◽  
Yanyan Wu ◽  
Patrick S Sullivan ◽  
Rob Stephenson
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Relationship Dynamics ◽  
Male Couples ◽  
Randomized Controlled ◽  
Electronic Health ◽  
Pilot Randomized Controlled Trial ◽  
Over Time

BACKGROUND There is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. OBJECTIVE We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). METHODS Eligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples’ relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. RESULTS Overall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; <i>P</i>=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. CONCLUSIONS The findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. CLINICALTRIAL ClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817

scholarly journals Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial

10.2196/16807 ◽  
2020 ◽  
Vol 4 (2) ◽  
pp. e16807 ◽  
Author(s):  
Jason William Mitchell ◽  
Ji-Young Lee ◽  
Yanyan Wu ◽  
Patrick S Sullivan ◽  
Rob Stephenson
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Relationship Dynamics ◽  
Male Couples ◽  
Randomized Controlled ◽  
Electronic Health ◽  
Pilot Randomized Controlled Trial ◽  
Over Time

Background There is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. Objective We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). Methods Eligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples’ relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. Results Overall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; P=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. Conclusions The findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. Trial Registration ClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817

scholarly journals Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER (Preprint)

2019 ◽  
Author(s):  
Michael E Newcomb ◽  
Elissa L Sarno ◽  
Emily Bettin ◽  
James Carey ◽  
Jody D Ciolino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Young Male ◽  
The United States ◽  
Relationship Education ◽  
Male Couples ◽  
Health And Wellbeing ◽  
Randomized Controlled

BACKGROUND Young men who have sex with men have a high HIV incidence, and a substantial proportion of incident infections occur in the context of main partnerships. However, romantic relationships also provide numerous benefits to individual health and wellbeing. 2GETHER is a relationship education and HIV prevention program for young male couples, and the 2GETHER USA randomized controlled trial (RCT) was launched to establish the efficacy of an online version of 2GETHER. OBJECTIVE The objective of 2GETHER is to optimize relationship functioning in young male couples as a method to improve communication about sexual risk behaviors and reduce HIV transmission. In the 2GETHER USA study, 2GETHER was adapted for online administration to couples across the United States via videoconferencing. The intervention in question aims to address the unique needs of couples from varied racial/ethnic backgrounds and geographic regions. METHODS This is a comparative effectiveness RCT of 2GETHER USA relative to existing public health practice (control). 2GETHER USA is a hybrid group- and individual-level intervention that delivers three weekly online group discussion sessions for skills delivery, followed by two individualized couple sessions that focus on skills implementation in each couple. The control condition differs by participant HIV status: (1) the Testing Together protocol for concordant HIV-negative couples; (2) medication adherence and risk reduction counseling for concordant HIV-positive couples; or (3) both protocols for serodiscordant couples. Follow-up assessments are delivered at 3-, 6-, 9-, and 12-months post-intervention in both conditions. Testing for rectal and urethral Chlamydia and Gonorrhea occurs at baseline and 12-month follow-up. The primary behavioral outcome is condomless anal sex with serodiscordant serious partners or any casual partners. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up. RESULTS As of October 11, 2019, the trial has enrolled and randomized 140 dyads (Individual N=280). Enrollment will continue until we randomize 200 dyads (N=400). Assessment of intervention outcomes at 3-, 6-, 9-, and 12-months is ongoing. CONCLUSIONS 2GETHER is innovative in that it integrates relationship education and HIV prevention for optimizing the health and wellbeing of young male couples. The 2GETHER USA online adaptation has the potential to reach couples across the United States and reduce barriers to accessing health care services that are affirming of sexual minority identities for those who live in rural or under-resourced areas. CLINICALTRIAL ClinicalTrials.gov NCT03284541; https://clinicaltrials.gov/ct2/show/NCT03284541 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15883

scholarly journals Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER

10.2196/15883 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15883 ◽  
Author(s):  
Michael E Newcomb ◽  
Elissa L Sarno ◽  
Emily Bettin ◽  
James Carey ◽  
Jody D Ciolino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Young Male ◽  
The United States ◽  
Relationship Education ◽  
Male Couples ◽  
Health And Wellbeing ◽  
Randomized Controlled

Background Young men who have sex with men have a high HIV incidence, and a substantial proportion of incident infections occur in the context of main partnerships. However, romantic relationships also provide numerous benefits to individual health and wellbeing. 2GETHER is a relationship education and HIV prevention program for young male couples, and the 2GETHER USA randomized controlled trial (RCT) was launched to establish the efficacy of an online version of 2GETHER. Objective The objective of 2GETHER is to optimize relationship functioning in young male couples as a method to improve communication about sexual risk behaviors and reduce HIV transmission. In the 2GETHER USA study, 2GETHER was adapted for online administration to couples across the United States via videoconferencing. The intervention in question aims to address the unique needs of couples from varied racial/ethnic backgrounds and geographic regions. Methods This is a comparative effectiveness RCT of 2GETHER USA relative to existing public health practice (control). 2GETHER USA is a hybrid group- and individual-level intervention that delivers three weekly online group discussion sessions for skills delivery, followed by two individualized couple sessions that focus on skills implementation in each couple. The control condition differs by participant HIV status: (1) the Testing Together protocol for concordant HIV-negative couples; (2) medication adherence and risk reduction counseling for concordant HIV-positive couples; or (3) both protocols for serodiscordant couples. Follow-up assessments are delivered at 3-, 6-, 9-, and 12-months post-intervention in both conditions. Testing for rectal and urethral Chlamydia and Gonorrhea occurs at baseline and 12-month follow-up. The primary behavioral outcome is condomless anal sex with serodiscordant serious partners or any casual partners. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up. Results As of October 11, 2019, the trial has enrolled and randomized 140 dyads (Individual N=280). Enrollment will continue until we randomize 200 dyads (N=400). Assessment of intervention outcomes at 3-, 6-, 9-, and 12-months is ongoing. Conclusions 2GETHER is innovative in that it integrates relationship education and HIV prevention for optimizing the health and wellbeing of young male couples. The 2GETHER USA online adaptation has the potential to reach couples across the United States and reduce barriers to accessing health care services that are affirming of sexual minority identities for those who live in rural or under-resourced areas. Trial Registration ClinicalTrials.gov NCT03284541; https://clinicaltrials.gov/ct2/show/NCT03284541 International Registered Report Identifier (IRRID) DERR1-10.2196/15883

scholarly journals A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Elliot Marrow ◽  
Matthew J Mimiaga ◽  
Patrick Sullivan ◽  
Lisa Hightow-Weidman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
Pilot Rct ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Beta Testing ◽  
Pilot Randomized Controlled Trial

BACKGROUND HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. OBJECTIVE The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. METHODS This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. RESULTS App refinement is underway. Enrollment for the pilot RCT began in October 2018. CONCLUSIONS MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10694

scholarly journals A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Christina Psaros ◽  
Douglas S Krakower ◽  
Elliot Marrow ◽  
Steven A Safren ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Young Men ◽  
The United States ◽  
Hiv Incidence ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Pilot Randomized Controlled Trial

BACKGROUND New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. OBJECTIVE This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). METHODS This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. RESULTS Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. CONCLUSIONS Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10661

scholarly journals Do Peers Increase Older Adults’ Participation in Strength Training? Pilot Randomized Trial

2020 ◽  
Vol 28 (5) ◽  
pp. 714-722
Author(s):  
Elissa Burton ◽  
Karen Levit ◽  
Jim Codde ◽  
Keith D. Hill ◽  
Anne-Marie Hill
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Strength Training ◽  
Lower Limb ◽  
Controlled Trial ◽  
Older Person ◽  
Randomized Controlled ◽  
Lower Limb Strength ◽  
Pilot Randomized Controlled Trial ◽  
Over Time

Fewer than 20% of older adults participate in strength training (ST). Barriers to ST participation include not knowing where to go or not having someone to go with. To address these barriers, the authors provided older adults with a peer (older person already participating in ST) to support their engagement. The aim of this pilot randomized controlled trial was to determine whether older adults who were provided with a peer when participating in ST were more likely to be participating in ST 4 weeks postintervention, compared with those receiving ST alone. Fifty-one ST participants were recruited; 40 completed the intervention and postintervention data collection (78.4%). Providing peer support with ST did not significantly increase ST participation (p = .775). However, both groups made significant improvements over time in lower-limb strength and mobility. Participants in either group who continued the ST program (55%) had made additional significant improvements in lower-limb strength and mobility.

scholarly journals Reducing HIV Vulnerability Through a Multilevel Life Skills Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Jose Bauermeister ◽  
Patrick S Sullivan ◽  
Laura Gravens ◽  
James Wolfe ◽  
Kristina Countryman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
San Francisco ◽  
Life Skills ◽  
Controlled Trial ◽  
Skills Training ◽  
The United States ◽  
Hiv Prevention Intervention ◽  
Randomized Controlled ◽  
Hiv Vulnerability

BACKGROUND Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths’ HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM. OBJECTIVE This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM. METHODS iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans. RESULTS This project is currently recruiting participants. Recruitment began in March 2018. CONCLUSIONS iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM. REGISTERED REPORT IDENTIFIER RR1-10.2196/10174

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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