NCT01930084

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,004

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

August 23, 2013

Last Update Submit

February 6, 2017

Conditions

HIV

Keywords

HIVlinkageretention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Time to linkage to care

    12 months

Other Outcomes (6)

  • 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

    12 months

  • +3 more other outcomes

Study Arms (3)

Combination intervention + incentives

EXPERIMENTAL

1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)

Other: Point of care CD4+ after HIV diagnosisOther: Accelerated ART initiationBehavioral: SMS appointment remindersOther: Non-cash Financial Incentives

Combination intervention strategy(CIS)

EXPERIMENTAL

1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders

Other: Point of care CD4+ after HIV diagnosisOther: Accelerated ART initiationBehavioral: SMS appointment reminders

Standard of care (SOC)

NO INTERVENTION

Standard of care, no intervention

Interventions

Point of care CD4+ after HIV diagnosisOTHER

Point of care (POC) CD4+ testing immediately following HIV diagnosis

Combination intervention + incentivesCombination intervention strategy(CIS)
Accelerated ART initiationOTHER

Accelerated ART initiation for eligible participants delivered by facility personnel

Combination intervention + incentivesCombination intervention strategy(CIS)
SMS appointment remindersBEHAVIORAL

Cellular appointment reminders delivered by study personnel

Combination intervention + incentivesCombination intervention strategy(CIS)
Non-cash Financial IncentivesOTHER

Non-cash Financial Incentives

Combination intervention + incentives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
  • Agreeing to be referred to the HIV care services associated with the SU
  • Agreeing to provide locator information
  • Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
  • Able to provide informed consent

You may not qualify if:

  • Being pregnant at study enrollment
  • Planning on leaving the community where they currently reside in the next 12 months
  • Enrolled in HIV care in the past 6 months at any clinic
  • Initiated ART (for any duration) in the past 6 months at any clinic
  • Currently on ART
  • Does not speak or understand Portuguese or Xitswa/Matswa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chicuque Health Center

Inhambane, Mozambique

Location

Massinga Health Center

Inhambane, Mozambique

Location

Maxixe Health Center

Inhambane, Mozambique

Location

Morrumbene Health Center

Inhambane, Mozambique

Location

Urbano Health Center

Inhambane, Mozambique

Location

Zavala Health Center and Inharrime Health Center

Inhambane, Mozambique

Location

Bagamoio Health Center

Maputo, Mozambique

Location

Jose Macamo Health Center

Maputo, Mozambique

Location

Mavalane General Hospital

Maputo, Mozambique

Location

Zimpeto Health Center

Maputo, Mozambique

Location

Related Publications (3)

  • 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.

    PMID: 29136001DERIVED

  • 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.

    PMID: 27930609DERIVED

  • 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.

    PMID: 25311998DERIVED

Study Officials

  • Batya Elul, PhD, MSc

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Epidemiology

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

MO(10)