Community-based Distribution of Oral HIV Self-testing Kits

NCT02994329 | Completed

• 1 other identifier: HIV-SELF 3IE
• Study Type: interventional
• Target: 8,080
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Keywords

HIV testing; Linkage to care

Outcome Measures

Primary Outcomes (1)

• The proportion of the total resident adult population who know their HIV status

  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

  3 Months

Secondary Outcomes (11)

• Proportion of total resident adult population who consent to participate in the intervention

  3 Months

• Proportion of male resident adult population who consent to participate in the intervention

  3 Months

• Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention

  3 Months

• Proportion of resident adolescent population who consent to participate in the intervention

  3 Months

• Proportion of all adults who consent to participate in the intervention who know their HIV status

  3 Months

Study Arms (2)

Oral HIV self test

ACTIVE COMPARATOR

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)

Standard of Care

NO INTERVENTION

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

Interventions

OraQuick® HIV Self-Test (Orasure Technologies, Thailand) DEVICE

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

Oral HIV self test

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in CHW zone
• Aged 16 years and above

You may not qualify if:

• age \<16
• unable to provide informed consent

Sponsors & Collaborators

• Zambart: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Zambart

Lusaka, 10101, Zambia

Location

Related Publications (4)

• Hensen B, Lewis JJ, Schaap A, Tembo M, Mutale W, Weiss HA, Hargreaves J, Ayles H. Factors associated with HIV-testing and acceptance of an offer of home-based testing by men in rural Zambia. AIDS Behav. 2015 Mar;19(3):492-504. doi: 10.1007/s10461-014-0866-0.

  PMID: 25096893 BACKGROUND

• Musheke M, Bond V, Merten S. Couple experiences of provider-initiated couple HIV testing in an antenatal clinic in Lusaka, Zambia: lessons for policy and practice. BMC Health Serv Res. 2013 Mar 14;13:97. doi: 10.1186/1472-6963-13-97.

  PMID: 23496926 BACKGROUND

• Doyle AM, Mavedzenge SN, Plummer ML, Ross DA. The sexual behaviour of adolescents in sub-Saharan Africa: patterns and trends from national surveys. Trop Med Int Health. 2012 Jul;17(7):796-807. doi: 10.1111/j.1365-3156.2012.03005.x. Epub 2012 May 18.

  PMID: 22594660 BACKGROUND

• Mulubwa C, Hensen B, Phiri MM, Shanaube K, Schaap AJ, Floyd S, Phiri CR, Bwalya C, Bond V, Simwinga M, Mwenge L, Fidler S, Hayes R, Mwinga A, Ayles H; HPTN 071 (PopART) Study Team. Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities. Lancet HIV. 2019 Feb;6(2):e81-e92. doi: 10.1016/S2352-3018(18)30258-3. Epub 2018 Dec 21.

  PMID: 30584047 DERIVED

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Alwyn Mwinga, PhD

  Zambart

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 15, 2016
• Study Start: January 18, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)