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Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk

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ClinicalTrials.gov Identifier: NCT03135067
Recruitment Status : Active, not recruiting
First Posted : May 1, 2017
Last Update Posted : February 22, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Impact Research & Development Organization
RTI International
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Provision of multiple self-tests Not Applicable

Detailed Description:

The study will recruit HIV-negative adult women who had two or more sexual partners within the past four weeks in the Nyanza region of Kenya. Beach communities and female sex worker hotspots will be randomized to an intervention group or a control group. In intervention clusters, participants will receive multiple oral fluid-based HIV test kits over a period of up to 24 months, training on how to use the tests, and encouragement to offer tests to current and potential sexual partners with whom sex without condoms is likely. In the comparison clusters, participants will be given referral vouchers for clinic-based HIV testing over a period of up to 24-months and encouraged to distribute these vouchers to sexual partners.

Data will be collected from study participants at baseline on demographic and socio-economic characteristics, self-reported sexual behavior, HIV testing history, intimate partner violence history, and mental health outcomes. Follow-up data collection will occur every 6 months. Each month, participants will be sent an invitation to participate in short mobile phone based text message surveys. HIV testing of participants will occur at baseline and at 6 monthly intervals.

Based on their reported use of the HIV self-tests, participants will be invited for qualitative interviews to learn more about their interactions with partners with regard to the distribution of self-tests and referral vouchers. Participants will also be given information to distribute to some of their male partners so that those partners can contact study staff to participate in qualitative interviews that will inquired about their perceptions of self-tests.

The study has 3 specific aims. Aim 1 will determine the intervention's effect on uptake of HIV testing and identification of HIV infection among participants' sexual partners, self-reported sexual behavior of participants with partners whose HIV status was HIV-positive or not known, and HIV incidence among participants. Aim 2 will use a mixed methods approach to assessing safety and perceptions of the intervention by participants and their sexual partners. Aim 3 will assess the cost-effectiveness of the intervention and obtain information necessary to inform scale-up of the intervention in Kenya and other countries.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Female sex worker hotspots and beach communities in the Nyanza region of Kenya will be grouped into clusters that will be randomly assigned to receive the intervention (provision of multiple HIV self-test kits over time) or control (provision of clinic-based HIV testing referral vouchers over time). About 66 clusters, with an average of 30 participants per cluster, will be selected for the study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Provision of multiple self-tests
Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis.
Behavioral: Provision of multiple self-tests
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.

No Intervention: Referral vouchers for VCT
Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling & testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.



Primary Outcome Measures :
  1. 18-month HIV incidence [ Time Frame: up to 24 months ]
    Proportion of participants who become HIV infected over an average follow-up period of 18 months


Secondary Outcome Measures :
  1. Identification of HIV-positive male partners [ Time Frame: up to 24 months ]
    Number of reported partners per participant who tested for HIV and obtained a reactive result

  2. Unprotected sexual encounters with partners whose HIV status is either HIV-positive or not known [ Time Frame: up to 24 months ]
    Proportion of unprotected sexual encounters that were with partners who were either HIV-positive or whose HIV status was unknown

  3. Cost-effectiveness [ Time Frame: up to 24 months ]
    Cost per disability-adjusted life year (DALY) averted. Calculation will be based on a) increased identification of HIV-positive men and the associated increase in antiretroviral therapy and b) fewer new HIV infections among women

  4. Couples testing [ Time Frame: up to 24 months ]
    Proportion of participants who report testing together with their primary partner

  5. Partner testing [ Time Frame: up to 24 months ]
    Proportion of participants who report that their primary partner tested for HIV since enrollment


Other Outcome Measures:
  1. Intimate Partner Violence (IPV) [ Time Frame: up to 24 months of follow-up ]
    Proportion of participants in each study group who experience IPV due to partner testing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Currently resides in the study area
  • Has resided in the study area for at least 6 months in the year prior to enrollment
  • Intends to stay in the study area for at least 24 months
  • Reports two or more sexual partners within the past 4 weeks at time of screening
  • HIV negative
  • Ownership or access to a mobile phone
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Younger than 18 years old
  • Does not currently live in the study area or has not for 6 of the last 12 months, or does not plan to for at least the next 24 months
  • Fewer than two sexual partners in the last four weeks at time of screening
  • HIV positive
  • Has no access to a mobile phone
  • Enrolled in another HIV prevention study
  • Cannot or will not provide informed consent

    • Males will self-select to participate by contacting the study staff using the information provided by willing index participants. There are no inclusion or exclusion criteria for the men who select to participate.

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): NCT03135067


Locations
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Kenya
Impact Research and Development Organization
Kisumu, Kenya
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Impact Research & Development Organization
RTI International
Investigators
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Principal Investigator: Harsha Thirumurthy, PhD University of North Carolina, Chapel Hill

Publications:
Unaids, THE GAP REPORT. 2014: Geneva, Switzerland.
Staveteig, S., et al., Demographic Patterns of HIV Testing Uptake in Sub-Saharan Africa. DHS Comparative Reports No. 30. Calverton, Maryland, USA: ICF International. 2013.
National AIDS and STI Control Programme (NASCOP), K., Kenya AIDS Indicator Survey 2012: Final Report. 2014, NASCOP: Nairobi.
National AIDS and STI Control Programme, Kenya AIDS Indicator Survey 2012: Nyanza Region Fact Sheet 2014, Nairobi, Kenya: NASCOP.
WHO, Preventing HIV in Sex Work Settings in sub Saharan Africa. 2011, World Health Organization: Geneva.
Thirumurthy, H., et al. Acceptability and feasibility of a novel approach to promote HIV testing in sexual and social networks using HIV self-tests. . in International AIDS Society (IAS) conference. 2015. Vancouver, Canada.
Kalibala, S., W. Tun, and W. Muraah, Feasibility and acceptability of HIV self testing among health care workers: results of a pilot programme in two hospitals in Kenya, in XVIII International AIDS Conference, Abstract WEPDC205, Editor. 2010: Vienna, Austria 18-23 July.
World Health Organization, Consolidated Guidelines on HIV Testing Services. 2015, World Health Organization: Geneva, Switzerland.
National AIDS and STD Control Programme, Guidelines for HIV Testing and Counselling in Kenya, Ministry of Public Health and Sanitation Kenya, Editor. 2008, Nairobi: NASCOP.
National AIDS and STI Control Programme, Guidelines for HIV Testing Services in Kenya. 2015, Nairobi: National AIDS Control Programme.
Orasure Techonologies, I., OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Package Insert. Accessed 14 September 2011 http://www.orasure.com/products-infectious/products-infectious-oraquick.asp: Bethlehem, PA.
Bernard, H.R., Research Methods in Anthropology. 1995, Walnut Creek Altamira Press 535.
Miles, M.H., A.H., Qualitative Data Analysis: An Expanded Sourcebook, 2nd Edition 1994, Thousand Oaks: Sage Publications

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03135067     History of Changes
Other Study ID Numbers: 16-1411
R01MH111602 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Pennsylvania:
HIV self-testing
female sex workers
partner testing
couples testing
transactional sex

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases