NCT03705611

Brief Summary

A three arm cluster randomized trial randomizing government primary health clinics to a) standard of care (SOC) with clinic invitation only; b) standard of care (SOC) and one self-test kit to give to sexual partner (s); c) standard of care (SOC) and self-test kit and monetary incentive given to partner conditional on clinic attendance and completion of pre-set procedures to determine secondary accuracy. Trial to be conducted in four districts (Blantyre, Zomba, Machinga and Chikwawa) in Malawi in collaboration with the Ministry of Health. Two primary outcomes:

  1. 1.proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus (HIV) within 28 days of enrolling the woman
  2. 2.Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

October 15, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

June 1, 2018

Last Update Submit

October 10, 2018

Conditions

HIV/AIDSHIV Infections

Keywords

Secondary distributionHIV self-testingMalawi

Outcome Measures

Primary Outcomes (2)

  • Proportion of partners tested for HIV

    For antenatal care clinic attendees, this is as reported by the women during their next antenatal care visit

    28 days

  • Number of newly diagnosed HIV positive people

    A count of number of sexual contacts of index HIV positive clients attending the clinic for post-test services

    28 days

Secondary Outcomes (2)

  • Proportion of partners of antenatal care clinic attendees who start HIV treatment, undergo circumcision, or attend discordant couples clinic

    28 days

  • Risk of adverse events (e.g. partnership breakdown, intimate partner violence, etc.) related to self-testing reported by antenatal care clinic attendees or HIV-positive index clients

    28 days

Study Arms (3)

Standard of care

NO INTERVENTION

Provide personalised clinic invitation slips (letters) to partners to come for HIV testing, and to access post-test services

HIV self-testing only

EXPERIMENTAL

HIV self-testing only

Diagnostic Test: HIV self-testing only

HIV self-testing secondary accuracy

EXPERIMENTAL

HIV self-testing secondary accuracy

Diagnostic Test: HIV self-testing onlyBehavioral: HIV self-testing secondary accuracy

Interventions

HIV self-testing onlyDIAGNOSTIC_TEST

Partners will be asked to self-test for HIV following receipt of the test kit from their sexual contact at home or in the community. They will also get information about the partner's clinic -- an HIV testing service room dedicated to providing HIV testing, confirmatory HIV testing, and referral to HIV treatment and prevention services including couples counselling.

Also known as: OraQuick, OraSure Technologies, USA
HIV self-testing onlyHIV self-testing secondary accuracy
HIV self-testing secondary accuracyBEHAVIORAL

A monetary incentive provided conditional on clinic attendance and fulfillment of secondary accuracy procedures such as undergoing on spot finger prick rapid HIV testing

HIV self-testing secondary accuracy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Government primary health clinic or centre
  • Provides antenatal care services, HIV testing services and HIV treatment services

You may not qualify if:

  • Not a government health facility
  • Does not provide antenatal care services, HIV testing services and HIV treatment services
  • Not willing to be part of the trial
  • Individual level eligibility screen for antenatal care attendees:
  • First antenatal care visit
  • Age 18 years or older
  • Has one main sexual partner (i.e. likely father)
  • Main sexual partner not already known to be HIV-positive and on antiretroviral therapy
  • Sexual partner likely to remain in clinic catchment area for the next 28 days
  • Not already tested together in this pregnancy \[e.g. partner has come with her on this visit and has tested today\]
  • Not already recruited in the study
  • Individual level eligibility screen for index clients:
  • Age 18 years or older
  • At least one sexual partner not already known to be HIV-positive and on antiretroviral therapy
  • At least one sexual partner likely to remain in catchment area within the next 28 days
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulanje District Hopsital

Mulanje, Malawi

RECRUITING

Related Publications (1)

  • Choko AT, Fielding K, Johnson CC, Kumwenda MK, Chilongosi R, Baggaley RC, Nyirenda R, Sande LA, Desmond N, Hatzold K, Neuman M, Corbett EL. Partner-delivered HIV self-test kits with and without financial incentives in antenatal care and index patients with HIV in Malawi: a three-arm, cluster-randomised controlled trial. Lancet Glob Health. 2021 Jul;9(7):e977-e988. doi: 10.1016/S2214-109X(21)00175-3.

    PMID: 34143996DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nicola Desmond, PhD

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Augustine T Choko, MSc

CONTACT

+265999577452augutc@mail.com

Elizabeth L Corbett, PhD

CONTACT

+265 999 981 439

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 1:1:1 randomization of primary health clinics (cluster randomized trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

October 15, 2018

Study Start

September 12, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

October 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Anonymised data relating to the primary and secondary outcomes will be made publicly available through the London School of Hygiene \& Tropical Medicine Data Campus

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After the main results have been published
Access Criteria
Contact the principal investigator for authorization to re-use the data
More information

Locations

MA(1)