NCT02887508

Brief Summary

The goal of this study was to empirically test a newly developed online HIV sexual risk reduction intervention (HINTS) among a representative sample of gay and bisexual men living with HIV who meet sex partners online.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

August 24, 2016

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexual risk behavior, such as condomless anal sex with sexual partners, will be assessed via a self-report survey. Data will be aggregated and reported as counts or occurrences.

    6 months

Study Arms (2)

HINTS Intervention

EXPERIMENTAL

The HINTS intervention consisted of an online four-session group intervention for 45 minutes, twice a week for two weeks. In each session, facilitators presented information, motivational skills, and behavioral skills related to a specific topic relevant to online partner seeking and transmission risk reduction, including Internet safety and communication, condom negotiation, and serostatus disclosure.

Behavioral: HINTS Intervention

Healthy Living Control

ACTIVE COMPARATOR

The Healthy Living Control condition consisted of an online four-session group intervention for 45 minutes, twice a week for two weeks. In each session, facilitators presented information, motivational skills, and behavioral skills to address non-sexual health-related topics particularly relevant to individuals living with HIV, such as nutrition, healthy eating, portion control, exercise and staying active, and stress reduction.

Behavioral: Healthy Living Control

Interventions

HINTS is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on sexual risk reduction.

HINTS Intervention

The Healthy Living Control is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on non-sexual health topics.

Healthy Living Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18 years of age
  • self-identifying as gay or bisexual
  • living with HIV/AIDS
  • reporting having used the Internet at least once to meet a potential sex partner
  • reporting any history of unprotected anal sex with a male partner.

You may not qualify if:

  • non-fluency in English
  • inability to participate in online group intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Burnham KE, Cruess DG, Kalichman MO, Grebler T, Cherry C, Kalichman SC. Trauma symptoms, internalized stigma, social support, and sexual risk behavior among HIV-positive gay and bisexual MSM who have sought sex partners online. AIDS Care. 2016;28(3):347-53. doi: 10.1080/09540121.2015.1096894. Epub 2015 Oct 13.

Related Links

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dean G Cruess, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 2, 2016

Study Start

December 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

September 2, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share