NCT01502618

Brief 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
Last Updated

February 28, 2017

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 10, 2011

Last Update Submit

February 27, 2017

Conditions

Keywords

Adolescent Medicine Trials Network for HIV/AIDS InterventionsHuman Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • 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: 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).

    1 year

Study Arms (1)

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.

Behavioral: Focus Group

Interventions

Focus GroupBEHAVIORAL

N/A. Protocol is the focus group

Focus Group

Eligibility Criteria

Age16 Years - 24 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Patrick Wilson, PhD

    Columbia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

December 30, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 28, 2017

Record last verified: 2016-05