HIV
Conditions
Keywords
HIV, HIV Counseling and Testing, Linkages to Care, Point of Care CD4, Point of Care Viral Load
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.
Interventions
OTHERCD4 Referral
Referral to CD4 testing
BEHAVIORALLay Counselor Follow-up
Follow-up from a lay counselor
OTHERPOC CD4 Testing
Point of Care CD4 testing
BEHAVIORALClinic Accompaniment
Accompaniment to the clinic by a counselor
BEHAVIORALClinic Referral
Referral to clinic
BEHAVIORALSMS Reminder
SMS reminder for male circumcision
BEHAVIORALCircumcision Promotion
Promotion of male circumcision at the time of HIV testing
OTHERPOC VL
POC VL testing for HIV infected persons on ART
OTHERLaboratory based VL assay
Laboratory based viral load testing for HIV infected persons on ART
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Africa, Uganda
Outcome results
None listed