Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men
Verified date | May 2016 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 16 Years to 24 Years |
Eligibility |
Inclusion Criteria: 1. Receives services at one of the selected AMTU sites; 2. Male sex at birth and male gender at the time of the study; 3. 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); 4. HIV-infected as documented by medical record review or verification with referring medical professional; 5. Between the ages of 16-24 years inclusive at the time of consent; 6. HIV-infected through sexual behavior; 7. At least one sexual encounter involving oral or anal sex with a male partner in the past year; 8. Ability to understand both written and spoken English; 9. Willingness to participate in a focus group discussion with other HIV-positive B-YMSM; and 10. Willingness to provide signed informed consent or assent with parental permission as applicable for study participation. Exclusion Criteria: 1. 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; 2. Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior); 3. 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; 4. 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of North Carolina, Chapel Hill |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
1 year |
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