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Community-based Distribution of Oral HIV Self-testing Kits

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ClinicalTrials.gov Identifier: NCT02994329
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Zambart

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.


Condition or disease Intervention/treatment Phase
HIV Seropositivity Device: OraQuick® HIV Self-Test (Orasure Technologies, Thailand) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community-based Distribution of Oral HIV Self-testing Kits-A Pilot Intervention and Rapid Impact Evaluation
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Oral HIV self test
In this arm, community health workers conducting door-to-door HIV testing will offer oral HIV self testing (OraQuick® HIV Self-Test (Orasure Technologies, Thailand)) as an alternative to standard of care finger-prick HIV testing for individuals who are present at the time of the visit. In addition they will provide demonstration to an adult who is present at the time of the visit and leave up to 2 oral HIV self test kits to allow testing with the partner
Device: OraQuick® HIV Self-Test (Orasure Technologies, Thailand)
All individuals aged 16 and above who are approached by community health workers conducting door-to door HIV testing will be offered the choice to use an oral HIV self test kit or to have standard of care finger-prick rapid HIV testing

No Intervention: Standard of Care
In this arm community health workers will conduct door-to-door HIV testing using the current Zambian national HIV testing algorithm of finger-prick rapid HIV tests



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of total resident adult population who consent to participate in the intervention [ Time Frame: 3 Months ]
  2. Proportion of male resident adult population who consent to participate in the intervention [ Time Frame: 3 Months ]
    Outcome 2 restricted to men

  3. 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

  4. 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

  5. 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

  6. 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

  7. Proportion of couples who test for HIV and receive results as a couple [ Time Frame: 3 Months ]
  8. Factors associated with uptake of and experience with HIV self testing [ Time Frame: 3 Months ]
    Qualitative data

  9. Linkage to HIV prevention and care [ Time Frame: 3 Months ]
  10. 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 ]
  11. 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



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

Inclusion Criteria:

  • Resident in CHW zone
  • Aged 16 years and above

Exclusion Criteria:

  • age <16
  • unable to provide informed consent

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): NCT02994329


Locations
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Zambia
Zambart
Lusaka, Zambia, 10101
Sponsors and Collaborators
Zambart
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Alwyn Mwinga, PhD Zambart

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zambart
ClinicalTrials.gov Identifier: NCT02994329     History of Changes
Other Study ID Numbers: HIV-SELF 3IE
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the de-identified data will be made available via International Initiative for Evaluation's (3ie) public access data repository.

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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 Zambart:
HIV testing
Linkage to care
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases