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 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 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

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group

2019 ◽  
Vol 160 (4) ◽  
pp. 687-694 ◽  
Author(s):  
Vijay Anand ◽  
Dennis Poe ◽  
Marc Dean ◽  
William Roberts ◽  
Pablo Stolovitzky ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Eustachian Tube ◽  
Controlled Trial ◽  
Balloon Dilation ◽  
The United States ◽  
Eustachian Tube Dysfunction ◽  
Randomized Controlled ◽  
Tube Dysfunction

Objective Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. Study Design Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. Setting Twenty-one investigational sites across the United States. Subjects and Methods Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. Results Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire–7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). Conclusions The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

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

scholarly journals Efficacy testing of the SAVOR (Sisters Adding Fruits and Vegetables for Optimal Results) intervention among African American women: A randomized controlled trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-280 ◽  
Author(s):  
LaVonne Brown ◽  
Manoj Sharma ◽  
Sophia Leggett ◽  
Jung Hye Sung ◽  
Russell L. Bennett ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
African American ◽  
African American Women ◽  
Fruits And Vegetables ◽  
Controlled Trial ◽  
Health Behavior Change ◽  
The United States ◽  
American Women ◽  
Randomized Controlled

Background: In the United States, only about 15% of individuals meet daily fruit intake recommendations of 2 cups per day and only 10% meet the vegetable intake recommendations of 3 cups per day. African American women are a high-risk group. In this study, a fourth-generation multi-theory model (MTM) of health behavior change was used to design and evaluate a Sisters Adding Fruits and Vegetables for Optimal Results (SAVOR) intervention for AA women. Methods: The study utilized a randomized controlled trial (RCT) with measurements taken at pretest, posttest (after the three-week intervention) and follow-up (at the end of eight weeks). SAVOR (n=26) was compared to an equivalent knowledge-based intervention (n=28). Process evaluation was done for program fidelity and satisfaction. A validated 38-item self-reported questionnaire was used to measure changes in MTM constructs and past 24-hour consumption of fruits and vegetables. Results: The SAVOR intervention resulted in improvement of mean consumption of fruits and vegetables in the experimental group from pre-test (2.78) to posttest (4.77) to recommended levels at follow-up (5.04) while in the comparison group they remained at around 3 (P<0.0001) Statistically significant changes (P<0.05) were noted for all MTM constructs except for participatory dialogue. Conclusion: The SAVOR intervention was found to be efficacious and established the robustness of MTM. SAVOR can be replicated for future effectiveness trials.

scholarly journals The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Macey L Henderson ◽  
Alvin G Thomas ◽  
Ann K Eno ◽  
Madeleine M Waldram ◽  
Jaclyn Bannon ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
The United States ◽  
Secondary Outcome ◽  
Hospital Level ◽  
Process Data ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. OBJECTIVE The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. METHODS We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. RESULTS We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. CONCLUSIONS This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11000

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