NCT02793804

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,005

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

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

June 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 14, 2018

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

June 3, 2016

Last Update Submit

May 8, 2018

Conditions

HIV

Keywords

HIV self-testingHIVZambia

Outcome Measures

Primary Outcomes (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

    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.

    12 months

Secondary Outcomes (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

    12 months

Study Arms (2)

Control

NO INTERVENTION

All HIV testing and counselling services will be conducted as currently.

HIV Self-Testing

EXPERIMENTAL

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)

Interventions

Oraquick (made in Thailand)DEVICE
HIV Self-Testing

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lusaka

Lusaka, Zambia

Location

Related Publications (2)

  • Neuman M, Hensen B, Mwinga A, Chintu N, Fielding KL, Handima N, Hatzold K, Johnson C, Mulubwa C, Nalubamba M, Otte Im Kampe E, Simwinga M, Smith G, Tsamwa D, Corbett EL, Ayles H. Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004543. doi: 10.1136/bmjgh-2020-004543.

    PMID: 34275868DERIVED

  • Neuman M, Indravudh P, Chilongosi R, d'Elbee M, Desmond N, Fielding K, Hensen B, Johnson C, Mkandawire P, Mwinga A, Nalubamba M, Ncube G, Nyirenda L, Nyrienda R, Kampe EOI, Taegtmeyer M, Terris-Prestholt F, Weiss HA, Hatzold K, Ayles H, Corbett EL. The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations. BMC Public Health. 2018 Nov 6;18(1):1234. doi: 10.1186/s12889-018-6120-3.

    PMID: 30400959DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 8, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 14, 2018

Record last verified: 2017-08

Locations

ZA(1)