Strategies to Increase HIV Testing, Linkages to Care, and... | NCT02038582

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POC CD4 & Clinic Accompaniment	Active Comparator	HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment	Other: POC CD4 Testing Behavioral: Clinic Accompaniment
POC CD4 & Lay Counselor	Active Comparator	HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up	Other: POC CD4 Testing Behavioral: Lay Counselor Follow-up
POC CD4 & Clinic Referral	Active Comparator	HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic	Other: POC CD4 Testing Behavioral: Clinic Referral
CD4 Referral & Clinic Accompaniment	Active Comparator	HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment	Other: CD4 Referral Behavioral: Clinic Accompaniment
CD4 Referral & Lay Counselor	Active Comparator	HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up

Name	Type	Description	Arm Group Labels	Other Names
POC CD4 Testing	Other	Point of Care CD4 testing	POC CD4 & Clinic Accompaniment POC CD4 & Clinic Referral POC CD4 & Lay Counselor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Up to 12 Months
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	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	Up to 9 months
Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral	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	Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing	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.	Up to 12 months

Eligibility Module

Name	Affiliation	Role
Connie Celum, MD, MPH	University of Washington	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Human Sciences Research Council (HSRC)		Sweetwaters	KwaZulu-Natal		South Africa
Intergrated Community Based Initivatives (ICOBI)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27126488	Derived	Barnabas RV, van Rooyen H, Tumwesigye E, Brantley J, Baeten JM, van Heerden A, Turyamureeba B, Joseph P, Krows M, Thomas KK, Schaafsma TT, Hughes JP, Celum C. Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda. Lancet HIV. 2016 May;3(5):e212-20. doi: 10.1016/S2352-3018(16)00020-5. Epub 2016 Mar 10.