Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Other: POC CD4 Testing
* Other: CD4 Referral
* Behavioral: Lay Counselor Follow-up
* Behavioral: Clinic Accompaniment
* Behavioral: Clinic Referral
* Behavioral: SMS Reminder
* Behavioral: Circumcision Promotion
* Other: POC VL
* Other: Laboratory based VL assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: POC CD4 & Clinic Accompaniment<br>HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment | Other: POC CD4 Testing<br>* Point of Care CD4 testing<br>Behavioral: Clinic Accompaniment<br>* Accompaniment to the clinic by a counselor<br>|
| Active Comparator: POC CD4 & Lay Counselor<br>HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up | Other: POC CD4 Testing<br>* Point of Care CD4 testing<br>Behavioral: Lay Counselor Follow-up<br>* Follow-up from a lay counselor<br>|
| Active Comparator: POC CD4 & Clinic Referral<br>HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic | Other: POC CD4 Testing<br>* Point of Care CD4 testing<br>Behavioral: Clinic Referral<br>* Referral to clinic<br>|
| Active Comparator: CD4 Referral & Clinic Accompaniment<br>HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment | Other: CD4 Referral<br>* Referral to CD4 testing<br>Behavioral: Clinic Accompaniment<br>* Accompaniment to the clinic by a counselor<br>|
| Active Comparator: CD4 Referral & Lay Counselor<br>HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up | Other: CD4 Referral<br>* Referral to CD4 testing<br>Behavioral: Lay Counselor Follow-up<br>* Follow-up from a lay counselor<br>|
| Active Comparator: CD4 Referral & Clinic Referral<br>HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic | Other: CD4 Referral<br>* Referral to CD4 testing<br>Behavioral: Clinic Referral<br>* Referral to clinic<br>|
| Active Comparator: Circumcision - SMS Reminder<br>HIV negative uncircumcised males, randomized to SMS reminder for male circumcision | Behavioral: SMS Reminder<br>* SMS reminder for male circumcision<br>|
| Active Comparator: Circumcision - Lay Counselor<br>HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision | Behavioral: Lay Counselor Follow-up<br>* Follow-up from a lay counselor<br>|
| Active Comparator: Circumcision - Promotion<br>HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing | Behavioral: Circumcision Promotion<br>* Promotion of male circumcision at the time of HIV testing<br>|
| Active Comparator: POC VL<br>HIV positive persons on ART, randomized to POC viral load testing | Other: POC VL<br>* POC VL testing for HIV infected persons on ART<br>|
| Active Comparator: Laboratory based VL assay<br>HIV positive persons on ART, randomized to laboratory based viral load testing | Other: Laboratory based VL assay<br>* Laboratory based viral load testing for HIV infected persons on ART<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Counseling and Testing, Linkages to Care, Point of Care CD4, Point of Care Viral Load