HIV-1 InfectionHINTSNCT02887508
HIV Internet Sex Study: Internet-based STI/HIV Prevention for HIV+ Internet Users
A study testing HINTS Intervention in people with HIV-1 Infection and Risk Reduction, run by University of Connecticut.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1 Infection, Risk Reduction
- What is being tested?
- HINTS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- non-fluency in English
- inability to participate in online group intervention
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1 Infection, Risk Reduction
- Being tested
- HINTS Intervention, Healthy Living Control
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HINTS InterventionBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Living Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startDec 2010
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dean Cruess, University of Connecticut
- Investigators
- Dean G Cruess, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887508
- Sponsor's protocol ID
- H10-217
- Other IDs
- R34MH087120
- Acronym
- HINTS
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26461452
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based STI/HIV Prevention for HIV+ Internet Users
- ClinicalTrials.gov ID
- NCT02887508
- Acronym / sponsor ID
- HINTS / H10-217
- Conditions
- HIV-1 Infection, Risk Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HINTS Intervention | Experimental | Behavioral: HINTS InterventionThe 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. |
| Healthy Living Control | Active comparator | Behavioral: Healthy Living ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- non-fluency in English
- inability to participate in online group intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HINTS InterventionHINTS 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. | Behavioural | HINTS Intervention |
| Healthy Living ControlThe 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. | Behavioural | Healthy Living Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Results publication: PubMed 26461452Burnham 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.
- Baseline manuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean G Cruess, PhD principal investigator
University of Connecticut
Questions about this trial
What is this clinical trial studying?
A study testing HINTS Intervention in people with HIV-1 Infection and Risk Reduction, run by University of Connecticut.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02887508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.