The economic evaluation of the HPTN071/PopART study

Last registered on January 11, 2022

Pre-Trial

Trial Information

General Information

Title
The economic evaluation of the HPTN071/PopART study
RCT ID
AEARCTR-0008789
Initial registration date
January 10, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 11, 2022, 9:10 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
Imperial College London

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2014-01-01
End date
2022-07-01
Secondary IDs
NCT01900977
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
HPTN071/PopART is a community randomized trial that is investigating whether a community-wide combination HIV prevention package including annual home-based HIV testing, active referral and the offer of immediate ART for those testing HIV-positive, along with the promotion of proven HIV prevention methods (such as voluntary medical male circumcision and condom use), will help to prevent transmission and substantially reduce new HIV infections. The study was conducted in 21 communities in Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total population of approximately 1.2 million individuals. The economic evaluation of the HPTN071/PopART trial is a secondary outcome of the study. It's objective is to determine the societal value of the trial with a cost-effectiveness analysis that compares the incremental benefits and costs of the PopART intervention against enhanced standard of HIV care in the study communities. The economic evaluation also analyses the impact of the intervention on other economic outcomes, including work productivity, inequality in incomes and access to healthcare, and impact on health-related quality-of-life.
External Link(s)

Registration Citation

Citation
Hauck, Katharina. 2022. "The economic evaluation of the HPTN071/PopART study." AEA RCT Registry. January 11. https://doi.org/10.1257/rct.8789
Experimental Details

Interventions

Intervention(s)
Arm A:
Universal Testing with Immediate Anti-retroviral therapy (ART)
Other: Universal Testing with immediate ART
Combination prevention package including: House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with immediate eligibility for ART; Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and prevention of mother-to-child transmission of HIV services available in the community; and Treatment of sexually transmitted infections (STIs) and provision of condoms at health units

Arm B:
ART according to National Guidelines
Other: Universal Testing with ART eligibility according to National Guidelines
Combination prevention package including: House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with ART eligibility according to national guidelines; Promotion of male circumcision and PMTCT services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and PMTCT services available in the community; and Treatment of STIs and provision of condoms at health units.

Arm C:
Standard of Care
Includes: Strengthening of HIV testing and ART services according to national guidelines at health facilities and other venues; Strengthening of male circumcision and PMTCT services available at health facilities and other venues in the community; and Treatment of STIs and provision of condoms at health facilities and other venues in the community.
Intervention Start Date
2014-01-01
Intervention End Date
2018-07-07

Primary Outcomes

Primary Outcomes (end points)
HIV incidence measured over 3 years in the Population Cohort, with the primary analysis including HIV incidence measured between Months 12 and 36 of the study. [ Time Frame: 3 years ]
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
1. HIV incidence over the first, second, and third years of follow-up [ Time Frame: 3 years ]

2. ART adherence and viral suppression [ Time Frame: 24 months ]: HIV viral load at 24 months in HIV-infected members of the Population Cohort who initiated HIV care and ART after commencement of the PopART intervention in the community

3. Herpes Simplex Virus -2 (HSV-2) incidence [ Time Frame: 12 months, 24 months, and 36 months ]
Incident HSV-2 infections at 12 months, 24 months, and 36 months for all individuals in the Population Cohort who were HSV-2-uninfected at enrollment

4. HIV disease progression, retention in care, and death [ Time Frame: 3 years ]

5. ART toxicity [ Time Frame: 3 years ]: ART safety and clinical events among Population Cohort participants initiating ART after commencement of the PopART intervention in the community, measured using routine health center data, and ART safety and clinical events among health center attendees who initiated ART after commencement of the PopART intervention in the community, measured using routine health center data

6. Sexual risk behavior [ Time Frame: 3 years ]: Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort

7. Case notification rate of tuberculosis (TB) [ Time Frame: 3 years ]: Case notification rates of bacteriologically-confirmed TB diagnosed among the general population of patients seeking care at health centers as recorded by health centers; TB mortality among TB cases in the community as recorded by health centers

8. HIV-related stigma [ Time Frame: 3 years ]: Self-reported data on stigma indicators at enrollment, 12 months, 24 months, and 36 months in the Population Cohort, Qualitative interviews in selected members of the general population in Arms A, B, and

9. Uptake of PMTCT [ Time Frame: 3 years ]: Self-reported use of services for PMTCT at Enrollment, 12 months, 24 months, and 36 months among HIV-infected women in the Population Cohort who had been pregnant in the prior 12 months; Uptake of PMTCT services at health centers; Uptake of PMTCT as indicated in data collected in households by CHiPs

10. Uptake of male circumcision [ Time Frame: 3 years ]: Self-reported circumcision status/uptake at Enrollment, 12 months, 24 months, and 36 months of men in the Population Cohort; Uptake of circumcision in the community as indicated in health center data; Uptake of circumcision as indicated in data collected in households by CHiPs

11. ART screening and uptake [ Time Frame: 3 years ]: The proportion of Population Cohort members, identified as HIV-infected who screen for ART eligibility, and who subsequently initiate ART; Proportion of community members, identified as HIV-infected in data from CHiP teams, who screen for ART eligibility, and who subsequently initiate ART, as indicated in health center data

12. HIV testing and retesting [ Time Frame: 3 years ]: Self-reported recent HIV testing at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort; The number of adults (16 years and older) in the household and the number of HIV tests performed as indicated in data from CHiP teams and health centers

13. Time between HIV diagnosis and initiation of care [ Time Frame: 3 years ]: The proportion of Population Cohort members initiating HIV care within 3 months of a positive HIV diagnosis; The proportion of community members initiating HIV care within 3 months of HIV diagnosis as indicated in data from CHiP teams (provision of HIV positive result) and health center data (date of care initiation)

14. Cost-effectiveness and costs and benefits of the PopART interventions (Time Frame: 3 years]
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The trial was conducted from 2014 through 2018, in 21 urban or periurban communities in Zambia and Western Cape Province, South Africa (total population, approximately 1 million; mean, approximately 50,000 per community). Each community was the catchment population of a government clinic. Communities were grouped in seven triplets matched on the basis of geographic location and estimated HIV prevalence. Communities in each triplet were randomly assigned to three trial groups in simultaneous public ceremonies. Restricted randomization was used to ensure balance across the trial groups with respect to population size, baseline ART coverage (the percentage of HIV-positive persons who were receiving ART), and HIV prevalence. Randomization and locations of the trial communities are shown in the supplement of Hayes et al (2019), available at https://www.nejm.org/doi/full/10.1056/NEJMoa1814556. Group A communities received a combination prevention intervention (described below) with universal ART. Group B communities received a combination prevention intervention with ART provided according to local guidelines. Group C communities did not receive a combination prevention intervention but received standard care at government clinics, including HIV testing and ART offered according to local guidelines.

The combination prevention intervention was delivered to group A and B communities. Specially trained community health workers (community HIV-care providers) delivered services at annual household visits (see the Supplementary Appendix). The community health workers worked in pairs, with each pair responsible for approximately 500 households. Data that were collected by the community health workers were used primarily to support service delivery but also to evaluate intervention coverage. At each visit, the community health workers offered HIV counseling and rapid testing, and they provided support for linkage to care and ART adherence for HIV-positive clients. They referred uncircumcised HIV-negative men for voluntary medical male circumcision and referred HIV-positive pregnant women for antenatal care, including prevention of mother-to-child HIV transmission. The community health workers also screened clients for symptoms of tuberculosis and sexually transmitted infections, with referral for diagnosis and treatment, and promoted and provided condoms. In all 21 communities, HIV care and ART were provided at local government clinics. In group A, these clinics offered ART irrespective of CD4 cell count throughout the trial, with written consent for patients initiating ART outside local guidelines until universal ART became standard. In groups B and C, the clinics provided ART initially at a CD4 threshold of 350 cells per microliter, which increased to 500 cells per microliter in 2014. Universal ART was offered from April 2016 onward (in Zambia) and October 2016 onward (in South Africa).
Experimental Design Details
Not available
Randomization Method
Public lottery
Randomization Unit
Communities
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
21 communities in Zambia and South Africa
Sample size: planned number of observations
total population included in the study were approximately 1million, approximately 50,000 per community; the economic evaluation collected data from 21 healthcare facilities, supplemented by study financial information and data from health administration in the two countries
Sample size (or number of clusters) by treatment arms
the primary and secondary outcomes were assessed in a population cohort with 48,301 participants. Four surveys were conducted between 2014 and 2018, including a baseline survey before start of the interventions
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Under the assumption of an HIV incidence in group C of 1.0 to 1.5 per 100 person-years, a between-community coefficient of variation within matched triplets of 0.15 to 0.20, a total of 2500 participants per community with 85% HIVnegative status at baseline, and 25% loss to follow-up over a period of 3 years, the power of the trial would exceed 75% or
IRB

Institutional Review Boards (IRBs)

IRB Name
London School of Hygiene and Tropical Medicine (6326) ethics committee and the Division of AIDS (DAIDS)
IRB Approval Date
2013-09-04
IRB Approval Number
Protocol ID 11865