HIV Internet Sex Study: Internet-based STI/HIV Prevention for HIV+ Internet Users

HIV-1 Infection Clinical Trial

— HINTS  

Official title:

Internet-based STI/HIV Prevention for HIV+ Internet Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887508
• Other study ID #: H10-217
• Secondary ID: R34MH087120
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 29, 2016
• Start date: December 2010
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Internet-based venues such as websites, chat rooms, blogs, and bulletin boards are becoming an increasingly popular means for HIV-positive men who have sex with men (MSM) to meet potential sex partners. The anonymity, quickness, and convenience offered by online venues allows for numerous potential sex partners to be identified and screened with the possibility to meet in person. However, there are potential health hazards associated with meeting sex partners online, including an increased risk of sexually transmitted infections (STIs), and thus there is an urgent need for online behavioral interventions to help reduce STI/HIV risks associated with Internet-initiated sexual liaisons. This research involves developmental intervention studies to design and field test an online, theory-based behavioral risk reduction intervention for HIV-positive MSM who use the Internet to meet potential sex partners. Guided by the Information-Motivation-Behavioral Skills (IMB) model of health promoting behaviors the investigators will conduct 3 stages of intervention development research, as follows: (1) perform initial interviews and focus groups with HIV-positive MSM who use the Internet to meet sex partners. Stage 1 will also bring together expert and community consultants to aid in the intervention development. Based on information gained from rapid formative studies, this first stage of research will directly lead to the development a novel online theory-based sexual risk reduction intervention; (2) test the feasibility and acceptability of the newly developed online STI/HIV risk reduction intervention with a sample of HIV-positive MSM who use the Internet to meet sexual partners. Stage 2 will also involve programming an audio-computer assisted interview for data collection; and (3) conduct a randomized field test to determine the potential efficacy of the risk reduction intervention for MSM who use the Internet to potentially meet sex partners. Participants in the field test will be randomly assigned to either receive the newly developed intervention or a time-matched attention comparison condition. Stage 3 will include testing for differences between groups on behavioral risk and Internet use outcomes across a 6-month follow-up period. The investigators will also examine the intervention effects on mediating and moderating constructs of information, motivation, and behavioral skills. The proposed intervention research will therefore develop new STI/HIV prevention strategies delivered exclusively online for use with people living with HIV/AIDS (PLWHA) who use the Internet to meet potential sex partners. The results from this study will provide preliminary data on which to conduct a larger-scale, randomized controlled clinical trial in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. being over 18 years of age

2. self-identifying as gay or bisexual

3. living with HIV/AIDS

4. reporting having used the Internet at least once to meet a potential sex partner

5. reporting any history of unprotected anal sex with a male partner.

Exclusion Criteria:

1. non-fluency in English

2. inability to participate in online group intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection
• Risk Reduction

Intervention

Behavioral:
• HINTS Intervention
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.
• Healthy Living Control
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Mental Health (NIMH)

References & 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):347-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Baseline manuscript