Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique (PLHIV)
Traditional Healers as Adherence Partners for PLHIV in Rural Mozambique
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Incorporating healers as anti-retroviral therapy adherence counselors can help reduce the crisis of HIV treatment abandonment. Healers are often accused of encouraging patients to abandon HIV care, but they can also serve as strong advocates for patient health. When healers were engaged as tuberculosis adherence counselors in South Africa, their patients were as successful as those supported by non-healer counselors. An innovative solution would be to engage trained healers as treatment partners to support medication and appointment adherence for people living with HIV.
Healers are well positioned to address reported patient concerns, including: (1) keeping a patients HIV status a secret while providing support; (2) assisting with partner disclosure and initiating community/clinical systems of assistance if gender base violence is threatened/occurs; and (3) advocating for patients during clinical visits to ensure quality care is provided. Other programs in sub-Saharan Africa have shown that incorporating healers into an allopathic health system as adherence supporters for TB treatment is feasible, but healer use in HIV treatment is not well-documented. This novel intervention would provide patients newly initiated on ART a choice to nominate a specially trained healer as a treatment partner, and assess acceptability, feasibility, and patient outcomes using an interrupted time series quasi-experimental design. Community-based treatment partners can improve pharmacy adherence and loss to follow up , while decreasing stigma and isolation.
Engaging healers to conduct counseling sessions in a community setting to improve ART adherence necessitates technical clinical and psycho-social training. The ART Adherence Support Worker Training program will be adapted and used to train healers to be quality treatment partners and advocates. The training will ensure healers have the knowledge and skills to effectively: (1) Educate people living with HIV about treatment and HIV care; (2) Assess serious medication side effects or HIV co-infections; (3) Counsel patients about safer strategies for partner disclosure (with assistance if needed); (4) Accompany the patient for each clinical appointment; and (5) Advocate for quality health care delivery when assisting each patient. The training team will conduct training of the healers. All patients initiating treatment will be screened for interest in having a healer treatment partner. Control and intervention patients will be followed for one year, allowing the investigators to compare outcomes at 12-months to study the effectiveness of healers as adherence partners.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zambezia
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Namacurra, Zambezia, 모잠비크
- Namacurra Sede Health Facility
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients: Individuals 18 years of age or older, HIV-infected, and newly enrolled in ART and treatment services at Namacurra Sede.
- Traditional Healers: Healers will be eligible to participate if the healer lives within 10 km of the Namacurra Sede, received previous training from FGH, is 18 years of age or older, speak Portuguese, and see at least one patient per month
Exclusion Criteria:
- Patients: Individuals that are currently pregnant, HIV-uninfected, and/or not yet enrolled in HIV care. Individuals who cannot give consent due to mental limitations or intoxication.
- Traditional Healers: Healers who believe they can effectively treat or cure HIV or other associated conditions will be excluded from the project.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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활성 비교기: Standard of Care
Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
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First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
다른 이름들:
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실험적: Traditional Healer Support Program
This group will receive standard of care as described above. In addition, the investigators will assess an intervention partnership with traditional healer including: community and clinic based support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. In addition, the healer will accompany the patient on all regularly scheduled clinical visits. |
First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
다른 이름들:
Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retention in Care
기간: Retention in care over 12 months
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We accessed the percentage of days where participants have medication.
For example, if a participant picked up a 30 day supply of medication on August 1st but did not collect their next medication until October 1st, the patient would only be considered retained for 50% of the time.
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Retention in care over 12 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Viral Load
기간: 12 months post-enrollment
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Patient viral load at 12 months to assess the impact of the intervention on HIV viral suppression.
HIV viral load tests are reported as the number of HIV copies in a milliliter (copies/mL) of blood using a reverse-transcriptase polymerase chain reaction (RT-PCR) test.
If the viral load measurement is high, it generally indicates that HIV is present and replicating.
Initial, untreated, and uncontrolled HIV viral loads can range as high as one million or more copies/mL.
Viral loads that are consistently less than 200 copies/mL indicate that the virus is adequately suppressed and that the risk of disease progression is low.
Viral load results below zero indicate that no virus was detected (this is how the outputs are recorded using the PRC test in the region.
We did not assess change in values over time.
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12 months post-enrollment
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Carolyn Audet, PhD, Vanderbilt University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 150217
- K01MH107255-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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