HIV InfectionNCT02556294
Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
A study testing Self-acceptance based intervention and HIV/STI counseling and testing in people with HIV Infection and Sexual Behavior, run by Massachusetts General Hospital at 3 sites in 2 countries.
Trial summary
India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Sexual Behavior, Health Behavior
- What is being tested?
- Self-acceptance based intervention and HIV/STI counseling and testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2015to Aug 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant has had anal sex with 4 or more male partners (protected or unprotected) in the past 4 months.
- Participant has had condomless anal sex with a man who was HIV unknown or serodiscordant in the past 4 months.
- Participant has a history of transactional sex activity in the past 4 months.
- Participant has been given a diagnosis of an STI in the past 4 months.
Who cannot join
- Participant does not identify as male
- Younger than 18
- Is unable to understand or consent to the procedures
- Is deemed by the local PI or study staff to be engaging in deception about the inclusion/exclusion criteria.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
The National Institute for Research in Tuberculosis
Chennai
The Humsafar Trust
Mumbai
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for HIV.
Read the detailed description
India has the world's third largest HIV epidemic, and MSM in India have an estimated seroprevalence of 14.7%. Many HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of HIV prevention interventions and therefore no evidenced based HIV prevention interventions this population. MSM in India are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which potentially increases the risk for HIV transmission to their wives.
This proposal is the culmination of our ongoing, successful > 10-year community based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. Our work, including extensive community advisory input, has identified self-acceptance as a key resilience variable that protects against both HIV risk and psychosocial distress. A field test and pilot randomized controlled trial of our behavioral intervention that addresses both HIV risk and self-acceptance showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior.
The current study is a two-arm randomized controlled trial to reduce HIV, STI and sexual transmission risk compared to HIV/STI counseling and testing alone.
- Conditions
- HIV Infection, Sexual Behavior, Health Behavior
- Being tested
- Self-acceptance based intervention, HIV/STI counseling and testing
- Keywords
- HIV risk behavior
- Medical subject headings
- HIV Infections, Sexual Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-acceptance based interventionBehavioural
The intervention will consist of HIV/STI counseling and testing as well as individual counseling sessions and group sessions. The primary focus of the group sessions are to help foster self-acceptance by the support from the group, as well as learn skills to reduce distress and HIV risk. The primary purpose of the individual sessions is to help develop and implement an individualized plan for HIV risk reduction, and, as needed and available, linkage to other services.
HIV/STI counseling and testingBehavioural
The counseling component is standard of care in India and will focus on HIV/STI risk and how to minimize risk. This is followed by biological testing for HIV and STIs.
| Study group | Role | What they receive |
|---|---|---|
| Self-acceptance behavioral intervention | Experimental | The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing. Receives: Behavioral: Self-acceptance based intervention; Behavioral: HIV/STI counseling and testing |
| Comparison/Control | Other | The comparison group will receive HIV and STI counseling and testing. Receives: Behavioral: HIV/STI counseling and testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency of condomless sex
Self-reported insertive or receptive anal sex without the use of a condom.
Measured: 4 month visit, 8 month visit, 12, month visit
Number of incident STIs from Baseline
Chlamydia, gonorrhea, syphilis, and HIV
Measured: 12 month visit
Secondary outcomes (2)
Changes in Psychosocial Mediators
Items will be used to measure potential psychosocial mediators (e.g. self-acceptance questionnaire, distress questionnaire) at each major visit.
Measured: Measured at baseline, 4, 8, 12 month visits
Cost-effectiveness of intervention
To assess the incremental cost-effectiveness of the experimental versus the comparison condition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The National Institute for Research in Tuberculosis, Indian Council of Medical Research, Sahodaran, The Humsafar Trust, Fenway Community Health
- Responsible party
- Principal investigator, Steven A. Safren, Massachusetts General Hospital
- Investigators
- Steven A Safren, PhD, Principal investigator, University of MiamiMatthew J Mimiaga, ScD, MPH, Principal investigator, Brown UniversityConall M O'Cleirigh, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556294
- Sponsor's protocol ID
- R01MH100627-01A1
- Other IDs
- R01MH100627-01A1
- Status last verified
- Oct 2019
- First submitted
- 23 Apr 2015
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Safren SA, Thomas B, Biello KB, Mayer KH, Rawat S, Dange A, Bedoya CA, Menon S, Anand V, Balu V, O'Cleirigh C, Klasko-Foster L, Baruah D, Swaminathan S, Mimiaga MJ. Strengthening resilience to reduce HIV risk in Indian MSM: a multicity, randomised, clinical efficacy trial. Lancet Glob Health. 2021 Apr;9(4):e446-e455. doi: 10.1016/S2214-109X(20)30547-7.
PubMed 33740407Mimiaga MJ, Thomas B, Mayer KH, Regenauer KS, Dange A, Andres Bedoya C, Rawat S, Balu V, O'Cleirigh C, Biello KB, Anand V, Swaminathan S, Safren SA. A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India: study protocol. BMC Public Health. 2018 Jul 18;18(1):890. doi: 10.1186/s12889-018-5838-2.
PubMed 30021566
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
- ClinicalTrials.gov ID
- NCT02556294
- Acronym / sponsor ID
- R01MH100627-01A1
- Conditions
- HIV Infection, Sexual Behavior, Health Behavior
- Keywords
- HIV risk behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The National Institute for Research in Tuberculosis, Indian Council of Medical Research, Sahodaran, The Humsafar Trust, Fenway Community Health
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 22 Sep 2015 (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.
India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for HIV.
Detailed description
India has the world's third largest HIV epidemic, and MSM in India have an estimated seroprevalence of 14.7%. Many HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of HIV prevention interventions and therefore no evidenced based HIV prevention interventions this population. MSM in India are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which potentially increases the risk for HIV transmission to their wives.
This proposal is the culmination of our ongoing, successful > 10-year community based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. Our work, including extensive community advisory input, has identified self-acceptance as a key resilience variable that protects against both HIV risk and psychosocial distress. A field test and pilot randomized controlled trial of our behavioral intervention that addresses both HIV risk and self-acceptance showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior.
The current study is a two-arm randomized controlled trial to reduce HIV, STI and sexual transmission risk compared to HIV/STI counseling and testing alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-acceptance behavioral intervention | Experimental | Behavioral: Self-acceptance based intervention, Behavioral: HIV/STI counseling and testingThe intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing. |
| Comparison/Control | Other | Behavioral: HIV/STI counseling and testingThe comparison group will receive HIV and STI counseling and testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has had anal sex with 4 or more male partners (protected or unprotected) in the past 4 months.
- Participant has had condomless anal sex with a man who was HIV unknown or serodiscordant in the past 4 months.
- Participant has a history of transactional sex activity in the past 4 months.
- Participant has been given a diagnosis of an STI in the past 4 months.
Key exclusion criteria (4 listed)
- Participant does not identify as male
- Younger than 18
- Is unable to understand or consent to the procedures
- Is deemed by the local PI or study staff to be engaging in deception about the inclusion/exclusion criteria.
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 |
|---|---|---|
| Self-acceptance based interventionThe intervention will consist of HIV/STI counseling and testing as well as individual counseling sessions and group sessions. The primary focus of the group sessions are to help foster self-acceptance by the support from the group, as well as learn skills to reduce distress and HIV risk. The primary purpose of the individual sessions is to help develop and implement an individualized plan for HIV risk reduction, and, as needed and available, linkage to other services. | Behavioural | Self-acceptance behavioral intervention |
| HIV/STI counseling and testingThe counseling component is standard of care in India and will focus on HIV/STI risk and how to minimize risk. This is followed by biological testing for HIV and STIs. | Behavioural | Comparison/Control, Self-acceptance behavioral intervention |
Primary outcome
Changes in frequency of condomless sex
Time frame: 4 month visit, 8 month visit, 12, month visit
Self-reported insertive or receptive anal sex without the use of a condom.
Number of incident STIs from Baseline
Time frame: 12 month visit
Chlamydia, gonorrhea, syphilis, and HIV
2 secondary outcomes
Changes in Psychosocial Mediators
Time frame: Measured at baseline, 4, 8, 12 month visits
Cost-effectiveness of intervention
Time frame: 12 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 23 Oct 2019.
- Derived from this study: PubMed 33740407Safren SA, Thomas B, Biello KB, Mayer KH, Rawat S, Dange A, Bedoya CA, Menon S, Anand V, Balu V, O'Cleirigh C, Klasko-Foster L, Baruah D, Swaminathan S, Mimiaga MJ. Strengthening resilience to reduce HIV risk in Indian MSM: a multicity, randomised, clinical efficacy trial. Lancet Glob Health. 2021 Apr;9(4):e446-e455. doi: 10.1016/S2214-109X(20)30547-7.
- Derived from this study: PubMed 30021566Mimiaga MJ, Thomas B, Mayer KH, Regenauer KS, Dange A, Andres Bedoya C, Rawat S, Balu V, O'Cleirigh C, Biello KB, Anand V, Swaminathan S, Safren SA. A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India: study protocol. BMC Public Health. 2018 Jul 18;18(1):890. doi: 10.1186/s12889-018-5838-2.
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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.
Steven A Safren, PhD principal investigator
University of Miami
Matthew J Mimiaga, ScD, MPH principal investigator
Brown University
Conall M O'Cleirigh, Ph.D. principal investigator
Massachusetts General Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-acceptance based intervention and HIV/STI counseling and testing in people with HIV Infection and Sexual Behavior, run by Massachusetts General Hospital at 3 sites in 2 countries.
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 4 inclusion and 4 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in frequency of condomless sex (time frame: 4 month visit, 8 month visit, 12, month visit). The study lists 2 primary outcomes in all. 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 NCT02556294, which also lists 2 linked publications.
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 23 Oct 2019.