NCT00267410

Brief Summary

This project will pilot test a step-by-step guide for community-based organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The main purpose of this program is to improve understanding of the processes needed for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation. The second purpose of the program is to increase the number of effective behavioral HIV prevention interventions for 18-24 year old sero-positive men of color who have sex with other men (MSM of color).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

3.4 years

First QC Date

December 20, 2005

Last Update Submit

September 10, 2012

Conditions

Keywords

HIVAdaptationBehavioral interventionsSeropositiveMSMHIV Seronegativity

Outcome Measures

Primary Outcomes (3)

  • Document the resources and activities required to adapt and implement the Healthy Relationships intervention model for young sero-positive MSM of color

    11/2005-9/2007

  • Measure the effectiveness of the newly-adapted intervention

    11/2005-9/2009

  • Assess CDC's guidance for adapting effective behavioral interventions for new populations.

    11/2005-11/2007

Secondary Outcomes (1)

  • Optimize service delivery

    11/2005-12/2009

Interventions

"Healthy Relationships," grounded in the social cognitive theory, is a five-session, group-level intervention originally designed for HIV-positive heterosexual individuals seeking skills-building and support around risk reduction, as well as disclosure of status and sexual preference. Through clip media and active role-plays, the intervention promotes the development of decision-making and problem-solving tools, empowering participants to make voluntary and informed decisions around disclosure and safer sex practices. This model was formally disseminated to AIDS Service Organizations as part of CDC's strategic plan - Advancing HIV Prevention, New Strategies for a Changing Epidemic - which focused on innovative strategies to recruit individuals into HIV testing, as well as a movement towards secondary prevention efforts.

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • MSM, at least 18 years old;
  • HIV-positive; and
  • Self-identified African Americans, English speaking African-born individuals and Latinos.

You may not qualify if:

  • Non-English speaking;
  • Under 18 years of age;
  • Serious mental illness which makes them unsuitable for interviewing (accommodation will be made for HIV-related cognitive deficits \& related illnesses);
  • Inebriated;
  • Has been interviewed before; and

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harlem United Community AIDS Center

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV Infections

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Soraya Elcock

    Harlem United Community AIDS Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

November 1, 2005

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations