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Human Immunodeficiency VirusNCT04805112

Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial

A study testing Provision of multiple self-tests in people with Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Kenya.

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

This randomized controlled trial will assess the feasibility, acceptability and impact of the provision of multiple oral-fluid based HIV self-test kits to HIV-negative adolescents aged 15-19 years to promote HIV testing among their sexual partners and couples testing. Read more about this study

Who is it for?
Ages 15 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Provision of multiple self-tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
1 siteKenya
Study dates
2 Mar 2021to 2 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

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 15 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Female
  • Aged 15-19 years
  • HIV-negative (willing to self-test onsite in the presence of the Research Assistant who is also a trained HIV counselor)
  • Has at least one current sexual partner she expects to meet at least twice in the next 3 months (not necessarily to have sex); this will provide opportunity for the participant to suggest/offer testing.
  • Resides in Siaya County and does not intend to relocate within 6 months from enrollment, to allow follow up to be completed and to conduct IDI with those selected.
  • Willing to be randomized into the partner self-testing or HTS referral groups.
Show all 9Show fewer
  • Reporting no incident of sexual, physical, emotional, or economic abuse in the last 12 months from the partner she intends to offer (Appendix 4) or refer for testing (Appendix 3) in the next 3 months and does not believe the partner will abuse her if she offers the self-test kits or HTS referral coupon.
  • Has a male partner who has not tested for 6 months or whose HIV status is unknown to her.
  • Agrees to give consent to participate in the study.

Who cannot join

  • Male
  • HIV-positive
  • Not willing to self-test onsite under in the presence of the Research Assistant
  • Aged <15 years or >19 years
  • Does not have a current sexual partner or does not expect to meet the partner at least twice in the next 3 months
  • Does not reside in Siaya County or intends to relocate within the next 6 months
Show all 10Show fewer
  • Not interested in obtaining HIV self-tests or HTS referral coupon for purposes of suggesting testing to their sexual partners
  • Reporting an incidence of sexual, physical, emotional or economic abuse in the last 12 months from the partner she would have offered self-test kit or referred for testing, or believes the partner may subject her to sexual, physical, emotional, or economic abuse if she offered them self-test kit or HTS coupon.
  • Has a male partner who tested within the last 6 months.
  • Does not give consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Impact Research & Development Organization

    Kisumu

Other trials in Kenya

About this study

This randomized controlled trial will assess the feasibility, acceptability and impact of the provision of multiple oral-fluid based HIV self-test kits to HIV-negative adolescents aged 15-19 years to promote HIV testing among their sexual partners and couples testing.

Read the detailed description

This study will recruit HIV-negative adolescents girls (AG) aged 15-19 years in Siaya County, western Kenya. The study will evaluate the impact of the provision of oral HIV self-testing on uptake of testing among partners of adolescent girls. We will randomize about 300 sexually active AG to either an intervention group that receives multiple oral self-test kits that they can choose to offer to their sexual partner(s) or to a control group that will be given multiple referral coupons that their partners can use for HIV testing at pre-selected HIV testing services (HTS) sites. We will collect data on whether the kits were offered, to whom they were offered, if they were accepted, if they were used and with what results, if known, and if the partners who obtained HIV-positive results sought confirmatory testing. We will also conduct in-depth interviews with a sub-set adolescents to explore their experiences in offering HIV self-testing to their male partners.

This study has 4 specific aims: i) determine whether adolescent girls can safely offer oral HIV self-tests to their partners; ii) assess whether oral self-testing improves uptake of HIV testing among partners of adolescent girls; iii) document adverse events associated with offering oral self-testing to sexual partners of adolescent girls; and iv) qualitatively explore the experiences of adolescent girls when offering self-test kits to their partners.

Being tested
Provision of multiple self-tests
Keywords
HIV self-testing, partner testing, couples testing, transactional sex, young women, adolescent girls, female sex workers
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • Provision of multiple self-testsBehavioural

    Participants will be given multiple Oraquick Advance HIV-1/2 test kits to distribute to their sexual partners for partner testing or couple testing. Phone interviews will be conducted with the participants to assess whether they provided a HIV self-test to their partner, if the test was used, how it was used (partner testing or couple testing), if the partner disclosed his results, the partner's reaction to the results, and if the partner went for confirmatory testing

Study groups in NCT04805112
Study groupRoleWhat they receive
Provision of multiple self-testsExperimentalParticipants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s). The participant will be instructed to encourage their partner to test himself alone [partner testing] or with the participant [couple testing]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information
Receives: Behavioral: Provision of multiple self-tests
Referral vouchers for clinic testingNo interventionParticipants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites. The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone [partner testing] or together with the participant [couple testing]. The coupon will also have information on testing and a list of facilities where he can go for HTS. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

What is being measured

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

  1. uptake of partner HIV testing

    proportion of partners that complete HIV testing

    Measured: 3 months

Secondary outcomes (8)

  1. Introduce testing

    proportion of participants who introduce testing to their partners

    Measured: 3 months

  2. Partner accept testing

    proportion of partners who were offered HIVST or referral coupon and accepted

    Measured: 3 months

  3. Partner testing

    proportion of participants who report their partner tested alone

    Measured: 3 months

  4. Couples testing

    proportion of participants who report testing with their partner

    Measured: 3 months

  5. Positive partner

    proportion of participants who report their partner test result was positive

    Measured: 3 months

  6. linked to care

    Proportion of participants who report their partners was linked to care

    Measured: 3 months

  7. Intimate partner violence

    proportion of participants in each study group who report intimate partner violence related to HIV testing

    Measured: 3 months

  8. Confirmatory testing for positive HIV self-test

    proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing

    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 posted18 Mar 2021
  2. Study start2 Mar 2021
  3. Primary completion19 Apr 2021
  4. Study completion2 Jul 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be recruited through the DREAMS (Determined, Resilient, Empowered, AIDS-Free, Mentored, Safe) program being implemented in Siaya County, western Kenya, as well as other community groups and venues, by the host institution (Impact Research and Development Organization, IRDO). Participants will be randomized in a 1:1 ratio to either an intervention group (receive multiple oral HIV self-test kits) or control (receive referral vouchers for clinic based testing). About 300 women will be recruited to patriciate in this study.
Masking
None (open label)
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805112
Sponsor's protocol ID
848410
Status last verified
Jul 2022
First submitted
16 Mar 2021
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Provision of multiple self-tests in people with Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Kenya.

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 9 inclusion and 10 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 20 Jul 2022. 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 Kenya. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

uptake of 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 NCT04805112.

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 20 Jul 2022.

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