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Clinical Trial Summary

This is an unblinded cluster-randomized study to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care in outpatient departments (OPD) and sexually transmitted infection (STI) clinics. The first aim of the study will be conducted in Malawi at 15 clusters among 15,000 individuals (15 years or older) to test the feasibility and cost-effectiveness of group HIV self-testing for patients in OPD and STI clinic waiting areas. The second aim of the study will be conducted in Malawi at 15 clusters among 7,500 individuals (15 years or older) to test the feasibility and cost-effectiveness of HIV self-testing for partners of newly identified HIV-positive clients.


Clinical Trial Description

This is an unblinded cluster randomized study to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care in outpatient departments (OPD) and sexually transmitted infection (STI) clinics. The study will be conducted in Malawi at 15 clusters among 15,000 individuals (15 years or older) for Aim 1 and 7,500 individuals (15 years or older) for Aim 2. Clusters will be randomized to one of three study arms: (1) standard of care for provider-initiated testing and counseling (PITC) for HIV; (2) optimized standard of care for PITC for HIV; and (3) group self-testing for HIV for Aim 1 and partner self-testing for HIV for Aim 2.

In Aim 1, the standard of care arm will receive no intervention for PITC, and the optimized standard of care arm will receive training and support for implementing the Malawi guidelines for PITC. The group self-testing arm will receive an intervention in which eligible patients at OPD and STI clinics will be given HIV self-test kits to use in the waiting area. Participants will present their self-test results to their provider, who will confirm their HIV diagnosis. On the same day, participants will complete a brief survey upon exiting the clinic. Survey and medical record data from the group self-testing arm will be compared to clinic registers from the standard of care and optimized standard of care arms to determine whether group self-testing is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.

In Aim 2, the standard of care arm will receive no intervention for partner notification and referral, and the optimized standard of care arm will receive training and support for implementing the Malawi guidelines for partner notification and referral. The partner self-testing arm will receive an intervention in which eligible patients at ART clinics will be referred to study staff to learn about partner notification and self-testing. Participants in the self-testing arm will be given one self-test kit for each of their sexual partners who have an unknown HIV status or who tested HIV-negative more than six months prior. Participants (index clients) will be given instructions on how their partner can complete the self-test and how to refer their partner(s) to care if they receive a positive result from the self-test. Partners will be instructed to complete the self-tests and return the used tests to a lockbox in their community or to a provider at the study site. Participants will complete a brief survey at the beginning of the intervention and another survey at their follow-up ART visit. Participants in the standard of care and optimized standard of care arms will complete a survey upon entry to the study for self-report data on partner notification and testing. Survey and medical record data from the partner self-testing arm will be compared to standard of care and optimized standard of care arms to determine whether partner self-testing is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03271307
Study type Interventional
Source University of California, Los Angeles
Contact Ashley R Bardon, MPH
Phone 310-486-7455
Email abardon@mednet.ucla.edu
Status Recruiting
Phase N/A
Start date September 25, 2017
Completion date September 2018

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