Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIV Self-Testing Africa Zambia (STAR Zambia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02793804
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
Zambart
Society for Family Health, Zambia
Liverpool School of Tropical Medicine
University College, London
Population Services International
World Health Organization
UNITAID
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
This study consists of a Cluster Randomised Trial (CRT) of community and facility-based HIVST distribution by the Society for Family Health (SFH) in multiple rural and peri-urban settings. The study will take place in 6 matched pairs of health facilities and their catchment areas have been selected for study inclusion in collaboration with the district medical office (DMO). One clinic catchment area from each pair will be randomly allocated to the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In the HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be conducted as currently.

Condition or disease Intervention/treatment Phase
HIV Device: Oraquick (made in Thailand) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Self-testing for HIV (HIVST) Amongst Urban, Peri-urban and Rural Communities in Zambia, Including a Cluster-randomised Trial of Community-based HIVST Distribution
Study Start Date : June 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Control
All HIV testing and counselling services will be conducted as currently.
Experimental: HIV Self-Testing
Community-based distribution agents (CBDA), including Voluntary Male Medical Circumcision (VMMC) mobilisers, will deliver OraQuick® HIV Self-Tests (Orasure Technologies, Thailand). The kits will also be available at the health facility.
Device: Oraquick (made in Thailand)



Primary Outcome Measures :
  1. Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report [ Time Frame: 12 months ]
    Recent testing will be measured by self-report and analyzed at the individual level. Respondents will be asked to answer the following question: "Have you tested for HIV within the past 12 months" as part of the baseline, midline, and endline surveys.


Secondary Outcome Measures :
  1. Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data [ Time Frame: 12 months ]
    Linkage to HIV care will be measured using clinic data. Self-testers will receive self-referral forms, and will be asked to bring these to clinics where they receive confirmatory testing and care. Clinic staff will log all clients seeking confirmatory testing following HIV self-testing. Data on linkage will be aggregated to the clinic level for analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults (≥ 18 years old)
  • Adolescents (16 and 17 years old)
  • Able and willing to provide informed consent
  • Residing within catchment area of a designated local health unit
  • Residing in a randomly selected household

Exclusion Criteria:

  • Unable and unwilling to provide informed consent
  • Residing outside the catchment area.
  • Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

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): NCT02793804


Locations
Layout table for location information
Zambia
Lusaka
Lusaka, Zambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Zambart
Society for Family Health, Zambia
Liverpool School of Tropical Medicine
University College, London
Population Services International
World Health Organization
UNITAID
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02793804    
Other Study ID Numbers: 10660
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: August 2017
Keywords provided by London School of Hygiene and Tropical Medicine:
HIV self-testing
HIV
Zambia