Clinical trial NCT01381653: An Innovative HIV Prevention Intervention Using Social Networking Technology
Official title: An Innovative HIV Prevention Intervention Using Social Networking Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Risk
Substance Use
Keywords: sexual risk
substance use
HIV prevention
intervention acceptability and feasibility
young men who have sex with men
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP; R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage high-risk young men who have sex with men (YMSM) via online social networking and aims to reduce both high-risk sexual behavior and drug use.

Detailed description: This pilot study entails a two-phase process. During Phase I, 15 former YMHP participants (intervention decliners and those who only completed one session) will participate in focus groups to advise us on the feasibility and pragmatic specifications of an HIV prevention intervention received via the IM (instant messaging) function of Facebook. Focus group transcripts will be examined to isolate key recommendations for modifying the intervention's structure and procedures. Focus groups will be reconvened for additional feedback on the modified intervention, followed by further adjustment. During Phase II, 40 high-risk YMSM (ages 18-29 and Facebook users) will be enrolled in a pilot of the modified intervention. The intervention will span 4 weeks and contain 8 bi-weekly 30 minute Motivational Interviewing (MI) chat-window sessions consisting of a sequential progression of intervention approaches tailored to each participant's readiness to change their drug use and high risk sexual behavior. Data from Phase II will include pre-post intervention behavioral risk assessments, as well as individual interviews with all 40 intervention participants for a qualitative evaluation regarding the feasibility and acceptability of the intervention's structure, and process. Findings from these interviews (and counselor focus group) will inform the fine-tuning of the intervention in preparation for a subsequent randomized control trial (RCT).

Eligibility criteria: Inclusion Criteria:

Phase I:

For the focus group portion of the study (N=20), we will invite former YMHP participants who declined the intervention or only completed one session, agreed to be contacted for future studies, indicated using Facebook, are still between the ages of 18-29 and live in NYC.

Phase II:

To qualify for the intervention portion of the study, participants must report

1. at least 5 days of drug use (of 1 or more of the following drugs: cocaine, methamphetamine (MA), or ecstasy (MDMA) in the prior three months;
2. high-risk sexual behavior (1 or more acts of unprotected insertive or receptive anal sex with a male partner of unknown or HIV+ serostatus), in the prior three months;
3. biologically male;
4. age 18 to 29;
5. HIV-;
6. reliable Internet access;
7. Facebook use at least four times per week;
8. able to write in English given that intervention participation involves writing;
9. NYC residency.

Exclusion Criteria:

Participants will be excluded for any of the following reasons:

1. Unstable, serious psychiatric symptoms;
2. Currently suicidal/homicidal;
3. Evidence of gross cognitive impairment;
4. Self-reported current enrollment in a drug or HIV-related intervention or research study.

We exclude those with serious cognitive or psychiatric impairments because this would compromise ability to participate, regardless of whether these impairments are attributed to drug use. Such impairments would make completion of assessments difficult.

Excluded participants will be referred to local community health and social services resources, for which we have established linkages to facilitate access to care regardless of ability to pay.

Primary outcomes:
measure: feasibility and acceptability of intervention delivery
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training
state: New York
Study officials:
affiliation: Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training
name: Corina T Lelutiu-Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: