Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa
- Conditions
- HIV
- Interventions
- Other: CD4 ReferralOther: POC CD4 TestingBehavioral: Circumcision PromotionBehavioral: SMS ReminderOther: POC VLOther: Laboratory based VL assayBehavioral: Clinic AccompanimentBehavioral: Clinic ReferralBehavioral: Lay Counselor Follow-up
- Registration Number
- NCT02038582
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2075
- 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.
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description POC CD4 & Clinic Accompaniment Clinic Accompaniment HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment CD4 Referral & Clinic Referral CD4 Referral HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic CD4 Referral & Clinic Referral Clinic Referral HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic POC CD4 & Lay Counselor Lay Counselor Follow-up HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up POC CD4 & Clinic Referral POC CD4 Testing HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic POC CD4 & Clinic Referral Clinic Referral HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic POC CD4 & Clinic Accompaniment POC CD4 Testing HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment CD4 Referral & Clinic Accompaniment CD4 Referral HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment CD4 Referral & Lay Counselor CD4 Referral HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up POC CD4 & Lay Counselor POC CD4 Testing HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up Circumcision - Lay Counselor Lay Counselor Follow-up HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision Circumcision - Promotion Circumcision Promotion HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing Circumcision - SMS Reminder SMS Reminder HIV negative uncircumcised males, randomized to SMS reminder for male circumcision CD4 Referral & Clinic Accompaniment Clinic Accompaniment HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment CD4 Referral & Lay Counselor Lay Counselor Follow-up HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up POC VL POC VL HIV positive persons on ART, randomized to POC viral load testing Laboratory based VL assay Laboratory based VL assay HIV positive persons on ART, randomized to laboratory based viral load testing
- Primary Outcome Measures
Name Time Method 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 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 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 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
- Secondary Outcome Measures
Name Time Method POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing Up to 12 months Proportion of HIV positive persons with viral load \<50 copies/mL at 3 months among those who receive POC viral load testing compared to those participants who receive standard laboratory-based viral load testing.
Trial Locations
- Locations (2)
Human Sciences Research Council (HSRC)
🇿🇦Sweetwaters, KwaZulu Natal, South Africa
Intergrated Community Based Initivatives (ICOBI)
🇺🇬Kabwohe, Bushenyi, Uganda