Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients

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. 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. 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.

Data analysed as intention to treat with all eligible antenatal care (ANC) attendees and index clients at each health facility as the denominator, with unpaired t-test used to compare each intervention arm to the standard of care (SOC).

Conditions

• HIV/AIDS
• HIV Infections

Interventions

DIAGNOSTIC_TEST

HIV self-testing only

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.

BEHAVIORAL

HIV self-testing secondary accuracy

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

Sponsors & Collaborators

• World Health Organization

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• UNITAID

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Nicola Desmond, PhD · Liverpool School of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-12

Primary Completion

2019-04-30

Completion

2019-04-30

Countries

• Malawi

Study Locations