Clinical Trial: Community-based Distribution of Oral HIV Self-testing Kits

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Community-based Distribution of Oral HIV Self-testing Kits-A Pilot Intervention and Rapid Impact Evaluation

Brief Summary:

This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV status among the general adult and adolescent population.

The primary outcome of the trial is the proportion of individuals who know their HIV status, defined as a self-report of being HIV positive or accepting testing (standard or self testing) from the CHW.

Embedded within the impact evaluation is a process evaluation that will explore the fidelity of the implementation of the intervention and outputs of the intervention. Qualitative data on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any impacts on relationships (including between couples and with CHW) associated with use of HIVST kits.


Detailed Summary:

Trial Purpose This cluster randomised trial will evaluate the impact of a pilot intervention of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of home-based rapid HIV testing, by community health workers (CHWs ) on knowledge of HIV status among the general adult and adolescent population.

Aim The overall aim of this trial is to investigate whether the inclusion of HIVST as an option for HIV testing, in addition to the offer of HIV testing with a finger-prick blood sample, increases the uptake of an offer of home-based HIV-testing overall relative to an offer of HIV testing with a finger-prick blood sample alone.

Secondary Objectives

  1. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW increases the uptake of an offer of HIV-testing among specific sub-populations including men, adolescents and individuals who have not previously tested relative to an offer of HIV testing with a finger-prick blood sample alone.
  2. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW increases the proportion of individuals' diagnosed HIV positive relative to an offer of HIV testing with a finger-prick blood sample alone.
  3. Measure linkage to HIV treatment and care, or prevention services when HIVST is included as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW and levels of couples-testing.

Trial Design This cluster randomised trial will r
Sponsor: Zambart

Current Primary Outcome: The proportion of the total resident adult population who know their HIV status [ Time Frame: 3 Months ]

Knowledge of know HIV status includes those individuals who self report to be HIV positive or who test using standard of care HIV tests or oral HIV self test kits with results reported


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of total resident adult population who consent to participate in the intervention [ Time Frame: 3 Months ]
  • Proportion of male resident adult population who consent to participate in the intervention [ Time Frame: 3 Months ]
    Outcome 2 restricted to men
  • Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention [ Time Frame: 3 Months ]
    Outcome 2 restricted to those community members who have not previously been reached
  • Proportion of resident adolescent population who consent to participate in the intervention [ Time Frame: 3 Months ]
    Outcome 2 restricted to adolescents aged 16-18 years
  • Proportion of all adults who consent to participate in the intervention who know their HIV status [ Time Frame: 3 Months ]
    Knowledge of HIV status defined as perproportions of couples who primary outcome
  • Proportion of adults who test for HIV amongst those eligible for testing [ Time Frame: 3 Months ]
    Eligibility for testing includes consent to participate in the intervention and not self-reporting being HIV positive
  • Proportion of couples who test for HIV and receive results as a couple [ Time Frame: 3 Months ]
  • Factors associated with uptake of and experience with HIV self testing [ Time Frame: 3 Months ]
    Qualitative data
  • Linkage to HIV prevention and care [ Time Frame: 3 Months ]
  • Incremental cost effectiveness of the addition of oral HIV self testing into a package of door-to- door HIV testing provided by CHW [ Time Frame: 3 Months ]
  • Reported social harms associated with HIV testing [ Time Frame: 3 Months ]
    Social harms will be defined as any adverse event occurring as a direct result of HIV testing including domestic violence, marital break up or suicide. Social harms will be solicited by directly asking participants to report any events and also by passive reporting by community members, advisory boards or other bodies


Original Secondary Outcome: Same as current

Information By: Zambart

Dates:
Date Received: November 30, 2016
Date Started: January 2017
Date Completion: May 2017
Last Updated: December 14, 2016
Last Verified: December 2016