HIVE4HNCT01930084
ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique
A study testing Point of care CD4+ after HIV diagnosis, Accelerated ART initiation and SMS appointment reminders in people with HIV, run by Columbia University at 10 sites in Mozambique.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Point of care CD4+ after HIV diagnosis, Accelerated ART initiation and SMS appointment reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,004 participants
- Where
- 10 sitesMozambique
- Study dates
- Apr 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Mozambique10 sites
Chicuque Health Center
Inhambane
Massinga Health Center
Inhambane
Maxixe Health Center
Inhambane
Morrumbene Health Center
Inhambane
Urbano Health Center
Inhambane
Zavala Health Center and Inharrime Health Center
Inhambane
Bagamoio Health Center
Maputo
Jose Macamo Health Center
Maputo
Mavalane General Hospital
Maputo
Zimpeto Health Center
Maputo
About this study
Official title: ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Point of care CD4+ after HIV diagnosis, Accelerated ART initiation, SMS appointment reminders, Non-cash Financial Incentives
- Keywords
- HIV, linkage, retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care CD4+ after HIV diagnosisOther
Point of care (POC) CD4+ testing immediately following HIV diagnosis
Accelerated ART initiationOther
Accelerated ART initiation for eligible participants delivered by facility personnel
SMS appointment remindersBehavioural
Cellular appointment reminders delivered by study personnel
Non-cash Financial IncentivesOther
Non-cash Financial Incentives
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Point of care CD4+ after HIV diagnosis; Other: Accelerated ART initiation; Behavioral: SMS appointment reminders; Other: 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 Receives: Other: Point of care CD4+ after HIV diagnosis; Other: Accelerated ART initiation; Behavioral: SMS appointment reminders |
| Standard of care (SOC) | No intervention | Standard of care, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month and 12 months after testing
Secondary outcomes (1)
Time to linkage to care
A decrease in the median time to linkage to care
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Batya Elul, Columbia University
- Investigators
- Batya Elul, PhD, MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930084
- Sponsor's protocol ID
- AAAL1354
- Other IDs
- USAID-OAA-A-12-00027
- Acronym
- E4H
- Status last verified
- Feb 2017
- First submitted
- 23 Aug 2013
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29136001Sutton 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.
PubMed 27930609Elul 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.
PubMed 25311998
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
- ClinicalTrials.gov ID
- NCT01930084
- Acronym / sponsor ID
- E4H / AAAL1354
- Conditions
- HIV
- Keywords
- HIV, linkage, retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination intervention + incentives | Experimental | Other: Point of care CD4+ after HIV diagnosis, Other: Accelerated ART initiation, Behavioral: SMS appointment reminders, Other: Non-cash Financial Incentives1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI) |
| Combination intervention strategy(CIS) | Experimental | Other: Point of care CD4+ after HIV diagnosis, Other: Accelerated ART initiation, Behavioral: SMS appointment reminders1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders |
| Standard of care (SOC) | No intervention | –Standard of care, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care CD4+ after HIV diagnosisPoint of care (POC) CD4+ testing immediately following HIV diagnosis | Other | Combination intervention + incentives, Combination intervention strategy(CIS) |
| Accelerated ART initiationAccelerated ART initiation for eligible participants delivered by facility personnel | Other | Combination intervention + incentives, Combination intervention strategy(CIS) |
| SMS appointment remindersCellular appointment reminders delivered by study personnel | Behavioural | Combination intervention + incentives, Combination intervention strategy(CIS) |
| Non-cash Financial IncentivesNon-cash Financial Incentives | Other | Combination intervention + incentives |
Primary outcome
Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing.
Time frame: 1 month and 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 secondary outcome
Time to linkage to care
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Derived from this study: PubMed 29136001Elul 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.
- Derived from this study: PubMed 27930609Sutton 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.
- Derived from this study: PubMed 25311998Elul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batya Elul, PhD, MSc principal investigator
Columbia University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care CD4+ after HIV diagnosis, Accelerated ART initiation and SMS appointment reminders in people with HIV, run by Columbia University at 10 sites in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (time frame: 1 month and 12 months after testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930084, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.