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Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe (CHIEDZA)

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ClinicalTrials.gov Identifier: NCT03719521
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Biomedical Research and Training Institute
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
A cluster randomised trial to determine the impact of an integrated community-based package of HIV services incorporating HIV testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health (SRH) services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.

Condition or disease Intervention/treatment Phase
HIV Infection Other: Community-based package of integrated HIV, SRH and general health services Not Applicable

Detailed Description:

Young people fare disproportionately poorly across the HIV care continuum compared to other age-groups; the prevalence of undiagnosed HIV is substantially higher, and coverage of and adherence to antiretroviral therapy is lower, resulting overall in worse virological outcomes.

Aim: The aim is to determine the impact of an integrated community-based package of HIV services incorporating HIV testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.

Design: This is a two-arm cluster-randomised trial in 24 clusters randomised 1:1 to standard of care or to the intervention package.

Intervention: Community-based package of services that includes: HIV testing and counselling, delivery of antiretroviral therapy, adherence support groups, mobile health, condoms, menstrual hygiene management, contraception and treatment of sexually transmitted infections, referral for voluntary medical male circumcision and cervical screening, risk reduction counselling and general health information and counselling. The intervention will be implemented over a two-year period. The intervention will be implemented in 12 clusters, each with a population of approximately 2500 16-24 year olds.

Study Outcomes: The study outcomes will be determined at a population level through a community cross-sectional survey among 18 to 24 year olds two years following the implementation of the intervention. The primary outcome is the proportion with HIV with a viral load <1000 copies/ml. The secondary outcomes will reflect each step of the HIV care cascade: proportion with HIV who know their HIV status, proportion of those who know their HIV-positive status who are currently taking antiretroviral therapy, proportion of those taking antiretroviral therapy who are virally suppressed. Sexual and reproductive health knowledge, risks and behaviour will also be assessed.

Study population: The end-line survey will recruit 1000 18-24 year olds per cluster (total 24,000).

Study sites: The study will be conducted in 3 provinces in Zimbabwe: Harare, Bulawayo and Mashonaland East.

Study Duration: The planned duration of the entire study will be 4 years


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Staff conducting the outcome survey will be masked to the arm allocation
Primary Purpose: Other
Official Title: Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe (CHIEDZA)
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Arm

Community-based provision of an integrated package of services over a 24 month period.

For all those aged 16-24 years residing in the intervention clusters: HIV testing, Sexual and reproductive health services (condoms, menstrual hygiene management, contraception, syndromic sexually transmitted infection (STI) treatment, referral for voluntary medical male circumcision, cervical screening), General health information and counselling. For those who are aged 16-24 years and test HIV-positive (or known HIV positive) within the intervention clusters: ART initiation and community-based treatment, adherence support.

Other: Community-based package of integrated HIV, SRH and general health services
HIV Testing and Counselling, SRH and HIV prevention Services and General Health Counselling for all 16-24 year olds and ART initiation and ongoing treatment and adherence support for those who test HIV positive
Other Name: Cluster-randomized trial

Active Comparator: Control Arm
Routine existing services
Other: Community-based package of integrated HIV, SRH and general health services
HIV Testing and Counselling, SRH and HIV prevention Services and General Health Counselling for all 16-24 year olds and ART initiation and ongoing treatment and adherence support for those who test HIV positive
Other Name: Cluster-randomized trial




Primary Outcome Measures :
  1. Viral suppression among HIV-positive individuals [ Time Frame: Measured after the 2 years of intervention. ]
    % of those with HIV with an HIV viral load <1000 copies /ml


Secondary Outcome Measures :
  1. Knowledge of HIV-positive status [ Time Frame: After 2 years of intervention ]
    % with an HIV-positive test who know they are HIV-positive

  2. Coverage of antiretroviral therapy (ART) among those who their positive HIV status [ Time Frame: After 2 years of the intervention ]
    % of those who know their positive HIV status who are currently taking ART

  3. Viral suppression among those who report taking ART [ Time Frame: After 2 years of the intervention ]
    % of those taking ART who have an HIV viral load <1000 copies /ml



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Reside within cluster boundaries
  • Aged 16 to 24 years

Exclusion Criteria:

  • Reside outside the cluster boundaries
  • Aged below 16 years
  • Aged above 24 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719521


Contacts
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Contact: Rashida A Ferrand, PhD +442079272577 rashida.ferrand@lshtm.ac.uk
Contact: Ethel Dauya, MPH +263 774452172 edauya@brti.co.zw

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Biomedical Research and Training Institute

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03719521     History of Changes
Other Study ID Numbers: 16124
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be placed in the London School of Hygiene and Tropical Medicine (LSHTM) research data repository. This repository will enable direct download of records with codebooks to enable replication of the data analyses. Data will be anonymised prior to release for data sharing. In addition, annotated questionnaires and STATA do-files used for data cleaning and analysis will be available. All databases will be password-protected and accessible to authorised personnel only. The LSHTM open access repository will also enable access to repository contents through a searchable index.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The study protocol and consent forms will be shared as soon as approved by ethical review boards. The clinical study report will be available on completion of the end line survey and the analytic code will be available 12 months after completion of the study
Access Criteria: Where individual data are concerned, the informed consent procedure will clarify the possibility of use of anonymised data by other researchers. Data users will be required to acknowledge the source of data and to ensure that the regulatory requirements of the Medical Research Council of Zimbabwe and other ethical bodies reviewing the projects are met.
URL: http://datacompass.lshtm.ac.uk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by London School of Hygiene and Tropical Medicine:
Adolescents
Youth
Sexual and reproductive health
Africa
community-based

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases