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AzTrials

HIV InfectionsHIVSSSANCT05074251

Evaluation of Secondary Distribution of HIV Self-screening Tests by Women With HIV

A study testing HIV self test and Counseling and referral for partner testing in people with HIV Infections and ART, run by University of California, Los Angeles at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections, ART, HIV Seropositivity
What is being tested?
HIV self test and Counseling and referral for partner testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSouth Africa
Study dates
20 Apr 2021to 24 Aug 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult female 18+ years old
  • confirmed HIV-positive or on ART
  • confirmed to currently have a male partner and are sexually active
  • male partner is of HIV- or unknown status
  • confirmed to have a cell phone that can read and respond to SMS/WhatsApp messages
  • confirmed to be able to consent to study participation (no language constraints or psychological issues that would make it difficult to consent to participate in the study)

Who cannot join

  • Failure to meet all of inclusion criteria

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Department of Health Clinics

    Nkangala, Mpumalanga

Other trials in South Africa

About this study

Official title: Pilot Study of Secondary Distribution of HIV Self-screening Tests by Women With HIV: An Innovative Strategy to Improve Testing, Identification, and Linkage to Treatment of Men in South Africa

Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.

  • To improve case finding among men in Nkangala we will evaluate how best to reach partners of PLHIV (newly diagnosed or on ART) with index testing by using HIV self-screening (HIVSS) and linkage to ART start.
  • Secondary distribution of HIV self-screening kits (HIVSS), whereby clients bring HIVSS kits to their partners, addresses barriers by enabling partners to screen themselves at their convenience and in the privacy of their homes.
Read more

Study Objectives: BroadReach in collaboration with UCLA, UCT and Nkangala DOH will pilot test an innovative index partner HIVSS strategy in one urban and one rural clinic to evaluate acceptability, barriers, and efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART.

  • In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 oraquick HIVSS with instructions and invitation to return for confirmatory testing.
  • In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per South African national guidelines).

Study design: Randomized control trial of n=180 WLHIV (90 in each arm) in four facilities (urban and rural) in the Nkangala district ensure that the results are generalizable.

Read the detailed description

Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.

  • To improve case finding among men in Nkangala we will evaluate how best to reach partners of PLHIV (newly diagnosed or on ART) with index testing by using HIV self-screening (HIVSS) and linkage to ART start.
  • Secondary distribution of HIV self-screening kits (HIVSS), whereby clients bring HIVSS kits to their partners, addresses barriers by enabling partners to screen themselves at their convenience and in the privacy of their homes.

We will partner with BroadReach Healthcare, a PEPFAR partner in South Africa, to pilot test an innovative index partner HIVSS strategy in one urban and one rural public health clinic in the Nkangala district of Mpumalanga Province to evaluate acceptability, barriers, and preliminary efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART. In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 HIVSSs with HIVSS instructions and invitation to return for confirmatory testing. In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per SA national guidelines). We will evaluate the following aims:

  1. Conduct a mixed-methods survey with N=180 HIV+ women to assess perceived acceptability and barriers (including perceived safety, IPV) to secondary HIVSS distribution by women to male partners.
  2. Test the feasibility and preliminary efficacy of secondary HIVSS distribution through a 1:1 randomized control trial in n=180 HIV+ women to assess, comparing standard of care to intervention arm:
  3. % of index women who self-report that they gave the HIVSS or standard of care referral for testing to their male partner
  4. % of male partners who either screened or tested for HIV assessed at 3 months after randomization (primary outcome)
  5. Measured via options of: index or partner self-report, SMS/WhatsApp of a picture of the used HIVSS sent by partner or index, return of a used self-test to the facility by either the index or partner, and/or partner coming into facility for with an invitation for confirmatory testing or SOC counseling referral c. % of male partners with a positive HIV screening/test result d. % of newly diagnosed male partners who initiate ART within 3 months of diagnosis e. % of those on ART with viral suppression after 6 months on ART (index and partners)
  6. In the intervention arm, we will assess acceptability and barriers (including safety/IPV) related to HIVSS distribution or use via surveys with all intervention participants who return for the study endline survey and a convenience samples of n=20 male partners (n=10 men who used HIVSS and n=10 men who did not use HIVSS)
Being tested
HIV self test, Counseling and referral for partner testing
Keywords
HIV self testing, HIV self screening, South Africa
Medical subject headings
HIV Infections, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV self testDiagnostic test

    Also called counseling on partner testing and HIV self testing

    For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use \& importance of partner testing, to take home to their partner(s).

  • Counseling and referral for partner testingBehavioural

    Counseling and refer participant's partner for facility based HIV testing

Study groups in NCT05074251
Study groupRoleWhat they receive
HIV self testingExperimentalHIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing
Receives: Diagnostic Test: HIV self test; Behavioral: Counseling and referral for partner testing
Standard of careActive comparatorIn the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing.
Receives: Behavioral: Counseling and referral for partner testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Partner HIV Testing

    proportion of index partners who report testing

    Measured: 3 months

Secondary outcomes (3)
  1. Positivity

    Proportion of male partners tested who test HIV+

    Measured: 3 months

  2. ART Initiation

    Proportion of male partners tested who initiate antiretroviral therapy (ART)

    Measured: 3 months

  3. Viral Suppression

    Proportion of male partners and index partners who achieve viral suppression

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start20 Apr 2021
  3. Primary completion6 Aug 2021
  4. Study completion24 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05074251
Sponsor's protocol ID
BRHIVSTSA1
Acronym
HIVSSSA
Status last verified
Mar 2023
First submitted
29 Sep 2021
Last updated
8 Dec 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will be made available upon request to study team

Publications

  • Joseph Davey DL, Wall KM, Naidoo N, Naidoo D, Xaba G, Serao C, Malone T, Dovel K. HIV testing and linkage to ART following secondary distribution of HIV self-test kits to male partners of women living with HIV: a pilot randomized control trial in Mpumalanga, South Africa. J Int AIDS Soc. 2022 Jun;25(6):e25937. doi: 10.1002/jia2.25937.

    PubMed 35690880

Questions about this trial

What is this clinical trial studying?

A study testing HIV self test and Counseling and referral for partner testing in people with HIV Infections and ART, run by University of California, Los Angeles at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Partner HIV Testing (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05074251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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