A Self-Guided Intervention to Promote Condom Use Among African American Males
The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.
One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Bell Flower Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- African American men
- 15 to 24 years of age
- able to read, write and comprehend English
- have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
- willing to use a condom
- does not intend to get a partner pregnant in the next 6 months
- consent to participate in the study
- client of the Bell Flower Clinic in Indianapolis, IN in the past 12 months
- has maintained a cell-phone number for the past three months and is willing to use it for data collection and incur fees for voice communication or text messaging it they do not have unlimited plans
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 제어
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실험적: Homework Intervention Strategy
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Participants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline in number of unprotected sex events at 2 months
기간: 30 days
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30 days
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Change from baseline in number of unprotected sex events at 4 months
기간: 30 days
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30 days
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Change from baseline in number of unprotected sex events at 7 months
기간: 30 days
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30 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months.
기간: 30 days
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30 days
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Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months.
기간: 30 days
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30 days
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Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months.
기간: 30 days
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30 days
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Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 2 months.
기간: 30 days
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30 days
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Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale (CCUSES) at 4 months.
기간: 30 days
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30 days
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Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months.
기간: 30 days
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30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Stephanie A Sanders, Ph.D., Indiana University
- 수석 연구원: William L Yarber, Ph.D., Indiana University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 5R21MH090892-02 (미국 NIH 보조금/계약)
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