Acquired Immunodeficiency SyndromeNCT01502618
Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)
A study testing Focus Group in people with Acquired Immunodeficiency Syndrome, run by University of North Carolina, Chapel Hill.
Trial summary
This study involves conducting formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive Black young men who have sex with men (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT). Read more about this study
- Who is it for?
- Ages 16 to 24 years, men only
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Focus Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2011
- 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 16 to 24 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Receives services at one of the selected AMTU sites;
- Male sex at birth and male gender at the time of the study;
- Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora);
- HIV-infected as documented by medical record review or verification with referring medical professional;
- Between the ages of 16-24 years inclusive at the time of consent;
- HIV-infected through sexual behavior;
Show all 10Show fewer
- At least one sexual encounter involving oral or anal sex with a male partner in the past year;
- Ability to understand both written and spoken English;
- Willingness to participate in a focus group discussion with other HIV-positive B-YMSM; and
- Willingness to provide signed informed consent or assent with parental permission as applicable for study participation.
Who cannot join
- Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
About this study
Official title: Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men
This study involves conducting formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive Black young men who have sex with men (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT). The formative research includes reviewing data and findings from relevant ATN protocols (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus groups with up to 32 HIV- positive B-YMSM.
Read the detailed description
Focus groups will be conducted at two Adolescent Medicine Trials Unit (AMTU) sites and will guide the selection of the intervention content areas and the development of the intervention manual. The intervention aims to increase participation in health promoting behaviors and improve self-worth and self-concept among HIV-positive B-YMSM. Specifically, the intervention aims to address the following health promoting behaviors: 1) increasing engagement in HIV treatment; 2) improving medication adherence; 3) reducing sexual risk behaviors; 4) reducing substance use behaviors; and 5) increasing HIV status disclosure.
Based on reviews of ATN 070 data and existing related interventions (ATN 068, ATN 073, Young Warriors, HLS), draft components of the intervention curriculum for B-YMSM will be developed. Four focus groups will then be convened (two per AMTU) with HIV-positive B-YMSM to a) obtain input on the draft intervention curriculum, b) refine intervention components, and c) examine psychosocial factors that may mediate or moderate the intervention effect. The focus groups will be implemented using a "Rapid Approach" which allows for a focus on key areas of inquiry by asking fewer questions and focusing on targeted responses of focus group participants. All focus groups will be digitally recorded and transcribed. The transcripts will be reviewed and data analyzed using a phenomenological approach; protocol team members and members of two Youth Advisory Boards (YABs), which will include youth who are existing members of ATN site CABs as well as youth recruited from other local agencies and organizations), will work on the analysis of the data.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Focus Group
- Keywords
- Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
N/A. Protocol is the focus group
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Experimental | The focus group participants for this study will be Black Young Men who have Sex with Men (B-YMSM) ages 16-24 years (inclusive) who are diagnosed as HIV-positive and receive medical care at one of the two participating AMTUs or their community partners. Receives: Behavioral: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM
The focus groups will be conducted to:
- determine the needs of the intervention
- participants' views on the content areas that should and should not be included in the newly developed intervention
- participants' views on the following areas of intervention design will also be obtained:
- the critical consciousness coaching technique;
- program structure (e.g., frequency, length, time);
- format (group sessions, individual sessions, combined sessions, internet sessions, weekend retreats); (d) session content (e.g., prevention skills, content areas, study incentives).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wilson, PhD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502618
- Sponsor's protocol ID
- ATN 090
- Status last verified
- May 2016
- First submitted
- 10 Mar 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT01502618
- Acronym / sponsor ID
- ATN 090
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Dec 2011 (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.
This study involves conducting formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive Black young men who have sex with men (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT). The formative research includes reviewing data and findings from relevant ATN protocols (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus groups with up to 32 HIV- positive B-YMSM.
Detailed description
Focus groups will be conducted at two Adolescent Medicine Trials Unit (AMTU) sites and will guide the selection of the intervention content areas and the development of the intervention manual. The intervention aims to increase participation in health promoting behaviors and improve self-worth and self-concept among HIV-positive B-YMSM. Specifically, the intervention aims to address the following health promoting behaviors: 1) increasing engagement in HIV treatment; 2) improving medication adherence; 3) reducing sexual risk behaviors; 4) reducing substance use behaviors; and 5) increasing HIV status disclosure.
Based on reviews of ATN 070 data and existing related interventions (ATN 068, ATN 073, Young Warriors, HLS), draft components of the intervention curriculum for B-YMSM will be developed. Four focus groups will then be convened (two per AMTU) with HIV-positive B-YMSM to a) obtain input on the draft intervention curriculum, b) refine intervention components, and c) examine psychosocial factors that may mediate or moderate the intervention effect. The focus groups will be implemented using a "Rapid Approach" which allows for a focus on key areas of inquiry by asking fewer questions and focusing on targeted responses of focus group participants. All focus groups will be digitally recorded and transcribed. The transcripts will be reviewed and data analyzed using a phenomenological approach; protocol team members and members of two Youth Advisory Boards (YABs), which will include youth who are existing members of ATN site CABs as well as youth recruited from other local agencies and organizations), will work on the analysis of the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Group | Experimental | Behavioral: Focus GroupThe focus group participants for this study will be Black Young Men who have Sex with Men (B-YMSM) ages 16-24 years (inclusive) who are diagnosed as HIV-positive and receive medical care at one of the two participating AMTUs or their community partners. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Receives services at one of the selected AMTU sites;
- Male sex at birth and male gender at the time of the study;
- Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora);
- HIV-infected as documented by medical record review or verification with referring medical professional;
- Between the ages of 16-24 years inclusive at the time of consent;
Key exclusion criteria (4 listed)
- Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
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 |
|---|---|---|
| Focus GroupN/A. Protocol is the focus group | Behavioural | Focus Group |
Primary outcome
Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM
Time frame: 1 year
The focus groups will be conducted to: 1. determine the needs of the intervention 2. participants' views on the content areas that should and should not be included in the newly developed intervention 3. participants' views on the following areas of intervention design will also be obtained: 1. the critical consciousness coaching technique; 2. program structure (e.g., frequency, length, time); 3. format (group sessions, individual sessions, combined sessions, internet sessions, weekend retreats); (d) session content (e.g., prevention skills, content areas, study incentives).
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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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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.
Patrick Wilson, PhD study chair
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group in people with Acquired Immunodeficiency Syndrome, run by University of North Carolina, Chapel Hill.
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 10 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 28 Feb 2017. 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?
Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.