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Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients (ANC/FRS)

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ClinicalTrials.gov Identifier: NCT03705611
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
World Health Organization
Liverpool School of Tropical Medicine
UNITAID
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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. 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).


Condition or disease Intervention/treatment Phase
HIV/AIDS HIV Infections Diagnostic Test: HIV self-testing only Behavioral: HIV self-testing secondary accuracy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1:1 randomization of primary health clinics (cluster randomized trial)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Secondary Distribution of HIV Self-tests Through Antenatal and HIV Testing Services: a Pragmatic Cluster-randomized Trial (STAR-ANC)
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of care
Provide personalised clinic invitation slips (letters) to partners to come for HIV testing, and to access post-test services
Experimental: HIV self-testing only
HIV self-testing only
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.
Other Name: OraQuick, OraSure Technologies, USA

Experimental: HIV self-testing secondary accuracy
HIV self-testing secondary accuracy
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.
Other Name: OraQuick, OraSure Technologies, USA

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




Primary Outcome Measures :
  1. Proportion of partners tested for HIV [ Time Frame: 28 days ]
    For antenatal care clinic attendees, this is as reported by the women during their next antenatal care visit

  2. Number of newly diagnosed HIV positive people [ Time Frame: 28 days ]
    A count of number of sexual contacts of index HIV positive clients attending the clinic for post-test services


Secondary Outcome Measures :
  1. Proportion of partners of antenatal care clinic attendees who start HIV treatment, undergo circumcision, or attend discordant couples clinic [ Time Frame: 28 days ]
  2. 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 [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for clinics (cluster):

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

Exclusion Criteria for clinics:

  • 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
  • Not already recruited in the study

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): NCT03705611


Contacts
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Contact: Augustine T Choko, MSc +265999577452 augutc@mail.com
Contact: Elizabeth L Corbett, PhD +265 999 981 439

Locations
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Malawi
Mulanje District Hopsital Recruiting
Mulanje, Malawi
Contact: Cecilia Ching'oma, Diploma         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
World Health Organization
Liverpool School of Tropical Medicine
UNITAID
Investigators
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Principal Investigator: Nicola Desmond, PhD Liverpool School of Tropical Medicine

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03705611     History of Changes
Other Study ID Numbers: 14916
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data relating to the primary and secondary outcomes will be made publicly available through the London School of Hygiene & Tropical Medicine Data Campus
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After the main results have been published
Access Criteria: Contact the principal investigator for authorization to re-use the data
URL: http://datacompass.lshtm.ac.uk/

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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 London School of Hygiene and Tropical Medicine:
Secondary distribution
HIV self-testing
Malawi
Additional relevant MeSH terms:
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HIV Infections
Neoplasm Metastasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes