Scale-up of an Internet-Delivered Study for HIV+ Men

NCT02023580 | Completed DMC

• 1 other identifier: R01MH100973-01A1
• Study Type: interventional
• Target: 1,197
• Locations: 1 country
• Sites: 1

Brief Summary

Although HIV testing and highly effective antiretroviral therapy (ART) have improved survival with HIV, the relatively low level of ART adherence presents a significant public health challenge in terms of the potential to transmit HIV. Preventing transmission in virally unsuppressed HIV+ MSM who have condomless anal sex (CAS) with serodiscordant partners can have a great public health impact. As new HIV infections in MSM have been attributed in part to increased access to sex partners online, it is critical to deliver behavioral interventions to HIV+ MSM online to reach many high-risk men at a relatively low cost. The investigators' theoretically-grounded HIV prevention videos about CAS, HIV disclosure, and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated significant reductions in CAS and significant increases in HIV status disclosure at 3-month follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT) for MSM, investigators found significant reductions in CAS among MSM in the video arm at 60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including serodiscordant CAS (SDCAS) at 60-day follow-up, compared to baseline. Based on these findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals, to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The investigators have identified a potentially highly effective and feasible risk reduction intervention approach for HIV+ MSM. With the commitment of POZ and a strong team of experts, the investigators propose to reshoot the videos to show the perspective of an HIV-positive man's experience with relationships and struggle ART adherence. The intervention videos will provide short doses for 10 online sessions (including boosters). We will target HIV+ MSM who are virally unsuppressed and monitor self-reported clinical indicators (i.e., viral load). Further, we will target online recruitment by race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM for balanced representation; improving retention with incentives and a proven online platform; including educational information about ART adherence; and cost and cost-effectiveness analyses for potentially averted HIV infections to determine health-related cost savings. Online, the investigators will recruit and follow a national sample of 1,500 high-risk, virally unsuppressed HIV+ MSM for 12 months.

Conditions

HIV

Keywords

Viral suppression; Sexual risk

Outcome Measures

Primary Outcomes (1)

• SDCAS

  We will measure whether there is a reduction, increase, or no change in serodiscordant condomless anal sex with HIV-negative or unknown status male sex partners across the two study arms.

  3 months, 6 months, 9 months, 12 months

Secondary Outcomes (1)

• HIV disclosure

  3 months, 6 months, 9 months, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

The Video Treatment arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. Between baseline and 3-month follow-up, men will view 6 video vignettes (participants will receive a link to view a video vignette once a week for 6 weeks). Based on our team's experience of attenuated intervention effects at 6 months, men will receive 4 video boosters, spaced 1 week apart, after the 6-month assessment survey. Spacing the dose over time can improve critical thinking. The additional videos will be a continuation of the dramatic series plus additional video scenes on disclosure and serodiscordant partnerships.

Behavioral: Video treatments

Control

ACTIVE COMPARATOR

The video control arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. The control arm will receive the same number (and timing of) video clips as the intervention arm, but from a non-theoretically driven gay-oriented show with videos that are similar in length in order to preserve dosing equality across both arms. As the video treatment arm will be provided efficacious theory-driven videos, investigators expect to find a significant decrease in sexual risk behaviors in the intervention arm, compared to the control arm. Should this occur by month 6, with agreement from the data safety monitoring board (DSMB), investigators will provide the control arm with the video treatments.

Behavioral: Video treatments

Interventions

Video treatments BEHAVIORAL

The treatment video vignettes to be delivered between Baseline and 3 Months include: 1) Condom use/anal sex without HIV status disclosure (potentially SDCAS); 2) Condom use/anal sex without HIV status disclosure and perceived responsibility; 3) Discussion of nondisclosure of HIV status prior to sex and perceived responsibility, STIs; 4) Stigma associated with disclosing HIV status to sex partners; 5) HIV/STI testing; and 6) Diagnosis of an STI; STI disclosure to sex partners and perceived responsibility. Video boosters to be delivered weekly for 4 weeks between 6 and 9 Months include: 7) HIV status disclosure, condom use, STIs; 8) STI disclosure to sex partners, disclosure to friends, serodiscordant partnerships; 9 \& 10) Support of HIV disclosure and perceived responsibility.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biologically male
• age 18 or over
• able to read and respond in English
• reside within the U.S.
• report CAS with any HIV-negative or unknown status male partners in the past 6 months
• identify as HIV-positive
• in the past year, report a detectable viral load OR report not being on ART and not knowing their viral load OR report past month suboptimal ART adherence
• report their race and ethnicity as White, Black or Hispanic
• be willing to participate in an online intervention study for 12 months
• have a working email address and cell phone number for intervention follow-up

You may not qualify if:

• HIV-negative or untested MSM
• women
• transgender persons
• anyone under age 18

Sponsors & Collaborators

• Public Health Solutions: lead
• Hunter College of City University of New York: collaborator
• Columbia University: collaborator
• City University of New York, School of Public Health: collaborator
• Emory University: collaborator

Study Sites (1)

Public Health Solutions

New York, New York, 10013, United States

Location

Related Publications (3)

• Yoon IS, Downing MJ Jr, Teran R, Chiasson MA, Houang ST, Parsons JT, Hirshfield S. Sexual risk taking and the HIV care continuum in an online sample of men who have sex with men. AIDS Care. 2018 Jul;30(7):921-929. doi: 10.1080/09540121.2017.1417535. Epub 2017 Dec 19.

  PMID: 29258341 RESULT

• Downing MJ Jr, Houang ST, Scheinmann R, Yoon IS, Chiasson MA, Hirshfield S. Engagement in Care, Psychological Distress, and Resilience are Associated with Sleep Quality among HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men. Sleep Health. 2016 Dec;2(4):322-329. doi: 10.1016/j.sleh.2016.08.002. Epub 2016 Sep 19.

  PMID: 28191491 RESULT

• Hirshfield S, Downing MJ Jr, Parsons JT, Grov C, Gordon RJ, Houang ST, Scheinmann R, Sullivan PS, Yoon IS, Anderson I, Chiasson MA. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 17;5(2):e125. doi: 10.2196/resprot.5554.

  PMID: 27315764 RESULT

Study Officials

• Sabina Hirshfield, PhD

  Public Health Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 30, 2013
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

US (1)