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| ID | Type | Description | Link |
|---|---|---|---|
| USAID-OAA-A-12-00027 | Other Grant/Funding Number | USAID |
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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.
Design: Two-arm cluster site-randomized trial with a pre-post intervention two-sample design nested in the intervention arm.
Study Population: The study population is any adult who tests HIV positive at the HIV counseling and testing points participating in this study. The study unit (SU), the level of randomization for the study, includes specific HIV counseling and testing points at primary health care clinics and the HIV care and treatment services located in the same health facility. A total of 10 SU will be included.
Sample Size: A total of 2,250 adults from the 10 study units will be included in the study, 750 in the SOC arm, 750 receiving CIS without FI and 750 receiving CIS+FI.
Participants will be enrolled and followed for 12 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination intervention + incentives | Experimental |
|
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| Combination intervention strategy(CIS) | Experimental |
|
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| Standard of care (SOC) | No Intervention | Standard of care, no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of care CD4+ after HIV diagnosis | Other | Point of care (POC) CD4+ testing immediately following HIV diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. | An increase in linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. Participants are considered to achieve this outcome if they successfully link to the SU HIV care services within 1 month of testing HIV positive as measured from the electronic patient-level database used at the HIV care clinic (EPTS). | 1 month and 12 months after testing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to linkage to care | A decrease in the median time to linkage to care | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from ART eligibility to ART initiation | 12 months | |
| Proportion of participants with new WHO Stage III/IV event or hospitalization | 12 months | |
| Mortality rate 12 months after HIV diagnosis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Batya Elul, PhD, MSc | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicuque Health Center | Inhambane | Mozambique | ||||
| Massinga Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29136001 | Derived | Elul B, Lamb MR, Lahuerta M, Abacassamo F, Ahoua L, Kujawski SA, Tomo M, Jani I. A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study. PLoS Med. 2017 Nov 14;14(11):e1002433. doi: 10.1371/journal.pmed.1002433. eCollection 2017 Nov. | |
| 27930609 |
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| Accelerated ART initiation | Other | Accelerated ART initiation for eligible participants delivered by facility personnel |
|
| SMS appointment reminders | Behavioral | Cellular appointment reminders delivered by study personnel |
|
| Non-cash Financial Incentives | Other | Non-cash Financial Incentives |
|
| 12 months |
| Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI | 12 months |
| Proportion of patients receiving POC CD4+ test, short message service (SMS) reminders, accelerated ART initiation (among those eligible based on POC CD4+ test result), and FI | 12 months |
| Proportion of patients reporting that interventions were highly acceptable | 12 months |
| Inhambane |
| Mozambique |
| Maxixe Health Center | Inhambane | Mozambique |
| Morrumbene Health Center | Inhambane | Mozambique |
| Urbano Health Center | Inhambane | Mozambique |
| Zavala Health Center and Inharrime Health Center | Inhambane | Mozambique |
| Bagamoio Health Center | Maputo | Mozambique |
| Jose Macamo Health Center | Maputo | Mozambique |
| Mavalane General Hospital | Maputo | Mozambique |
| Zimpeto Health Center | Maputo | Mozambique |
| Sutton R, Lahuerta M, Abacassamo F, Ahoua L, Tomo M, Lamb MR, Elul B. Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S29-S36. doi: 10.1097/QAI.0000000000001208. |
| 25311998 | Derived | Elul B, Lahuerta M, Abacassamo F, Lamb MR, Ahoua L, McNairy ML, Tomo M, Horowitz D, Sutton R, Mussa A, Gurr D, Jani I. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study. BMC Infect Dis. 2014 Oct 15;14:549. doi: 10.1186/s12879-014-0549-5. |