An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,075
- 试验地点
- 2
- 主要终点
- Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing
研究概览
简要总结
The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.
详细描述
New strategies for HIV testing and linkages to care are needed, since only a minority of African adults have been tested in many settings and a drop-off occurs at each step from HIV and CD4 testing, remaining in pre-ART (antiretroviral therapy) care, ART initiation, and adherence over the long term.
This study aims to determine the effects of Point-of-Care (POC) CD4 testing, POC viral load (VL) testing and several linkage strategies (lay-counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinical referral) on linkage to care and treatment adherence for HIV positive persons.
This study also aims to determine the uptake of voluntary circumcision among HIV uninfected males with either promotion at point of HIV testing, Short Message Service (SMS) follow-up or lay counselor follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reside in the study community
- •Must be 16 years or older
- •Able and willing to provide informed consent/assent for study procedures
- •HIV negative uncircumcised men must be age 16 - 49 years and have access to secure text messaging to be randomized to strategies for male circumcision.
排除标准
- 未提供
研究组 & 干预措施
POC CD4 & Clinic Accompaniment
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment
干预措施: POC CD4 Testing (Other)
POC CD4 & Clinic Accompaniment
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment
干预措施: Clinic Accompaniment (Behavioral)
POC CD4 & Lay Counselor
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up
干预措施: POC CD4 Testing (Other)
POC CD4 & Lay Counselor
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up
干预措施: Lay Counselor Follow-up (Behavioral)
POC CD4 & Clinic Referral
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic
干预措施: POC CD4 Testing (Other)
POC CD4 & Clinic Referral
HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic
干预措施: Clinic Referral (Behavioral)
CD4 Referral & Clinic Accompaniment
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment
干预措施: CD4 Referral (Other)
CD4 Referral & Clinic Accompaniment
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment
干预措施: Clinic Accompaniment (Behavioral)
POC VL
HIV positive persons on ART, randomized to POC viral load testing
干预措施: POC VL (Other)
Laboratory based VL assay
HIV positive persons on ART, randomized to laboratory based viral load testing
干预措施: Laboratory based VL assay (Other)
Circumcision - Promotion
HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing
干预措施: Circumcision Promotion (Behavioral)
CD4 Referral & Lay Counselor
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up
干预措施: CD4 Referral (Other)
CD4 Referral & Lay Counselor
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up
干预措施: Lay Counselor Follow-up (Behavioral)
CD4 Referral & Clinic Referral
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic
干预措施: CD4 Referral (Other)
CD4 Referral & Clinic Referral
HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic
干预措施: Clinic Referral (Behavioral)
Circumcision - SMS Reminder
HIV negative uncircumcised males, randomized to SMS reminder for male circumcision
干预措施: SMS Reminder (Behavioral)
Circumcision - Lay Counselor
HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision
干预措施: Lay Counselor Follow-up (Behavioral)
结局指标
主要结局
Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing
时间窗: Up to 12 Months
Proportion of HIV positive individuals in the POC CD4 arm who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load \<50 copies/mL within 9 months compared to those in the clinic referral arm.
Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits
时间窗: Up to 9 months
Proportion of HIV-uninfected men who visit a male circumcision clinic or outreach venue for information about circumcision and proportion who report being circumcised by month 3 and 9 in the lay-counselor arm compared to the SMS follow-up arm, and male circumcision promotion at HIV testing arm
Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral
时间窗: Up to 12 months
Proportion of HIV positive individuals not on ART at baseline who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load \<50 copies/mL within 9 months in the lay counselor follow-up arm compared to the accompaniment and clinic referral arms
次要结局
- POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing(Up to 12 months)
研究者
Connie Celum
Professor of Medicine, Epidemiology and Global Health
University of Washington