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

August 29, 2016 updated by: Dean Cruess, University of Connecticut

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HINTS Intervention
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
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.
Active Comparator: Healthy Living Control
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dean G Cruess, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H10-217
  • R34MH087120 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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