The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
연구 개요
상세 설명
Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.
The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Masaka, 우간다
- MRC/UVRI Uganda Research Unit on AIDS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
HIV-infected participants
Inclusion Criteria:
- HIV-infected adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion Criteria:
- Previous or current receipt of HIV care from an ART provider
- On-going participation in other health-related research
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
HIV-uninfected participants
Inclusion criteria:
- HIV negative adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion criteria:
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Follow-up counselling
Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.
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간섭 없음: Standard of care
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
기간: 6 months
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6 months
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The time between HIV diagnosis and linkage to pre-ART care.
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
기간 |
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Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
기간: 6 months
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6 months
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The time between learning that a participant is eligible for ART and ART initiation
기간: 6 months
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6 months
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The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
기간: 6 months
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6 months
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기타 결과 측정
결과 측정 |
기간 |
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The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
기간: 6 months
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eugene Ruzagira, MRC/UVRI and LSHTM Uganda Research Unit
간행물 및 유용한 링크
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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