NCT01224184

Brief Summary

The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started May 2010

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

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

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

October 13, 2010

Last Update Submit

January 6, 2025

Conditions

HIVSexual RiskSexually Transmitted DiseasesSubstance AbuseViolenceVictimization

Keywords

HIVSexually Transmitted DiseasesSubstance Abuse DetectionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Changes in behaviors, including condom use, substance use and violence prevention

    3, and 6- months post-intervention

Study Arms (2)

Nutrition

ACTIVE COMPARATOR

Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.

Behavioral: Staying Healthy and Eating Well

Young Women's

EXPERIMENTAL

Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (Principal Investigator (PI): Dr. Wendee M. Wechsberg).

Behavioral: Young Women's CoOp

Interventions

Young Women's CoOpBEHAVIORAL

Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).

Young Women's
Staying Healthy and Eating WellBEHAVIORAL

Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.

Nutrition

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Black/African-American
  • years of age
  • Have dropped out of school at least once or are having problems that they have considered dropping out of school, and have not yet completed high school or GED program
  • Have not graduated from a high school or alternative school, or completed a General Education Development (GED) program
  • Have had vaginal sex at least once in the past 90 days with a male partner
  • Have used one of the following at least once in the past 90 days--alcohol, marijuana, cocaine/crack, heroin, ecstasy, methamphetamine, any prescription drugs not prescribed to them, or any other illicit substance.
  • Will be in the area for the next 8 months
  • Has not participated in previous formative activities of the study (e.g., interviews, focus groups, pretesting and pilot testing),

You may not qualify if:

  • Not interested in coming to a health behavior study
  • Not able to attend 4 sessions and 2 follow ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham

Durham, North Carolina, 27703, United States

Location

RTI International - Headquarters

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (2)

  • Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.

    PMID: 21473554BACKGROUND

  • Browne, F. A., Wechsberg, W. M., White, V. L., Middlesteadt Ellerson, R., Raiford, R. L., Carry, M. G., Herbst, J.H. (in press).

    BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted DiseasesSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Felicia Browne, ScD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 19, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

US(2)