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Completed

NCT Number: NCT04774835

Assisted Partner Services and HIVST in Western Kenya

This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aim 1:

  • Men and women
  • Tests HIV positive and is not in care or on treatment
  • ≥18 years old
  • Willing and able to provide informed consent
  • Able to provide locator information for sexual partners

Aim 2:

  • ≥18 years old
  • Willing and able to provide informed consent

Exclusion criteria

Aim 1:

  • Pregnancy
  • Reports intimate partner violence during last month
  • <18 years old

Aim 2:

  • <18 years old

Treatment and study plan

HIVST

Diagnostic Test

aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV self-testing by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.

Standard aPS

Diagnostic Test

aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV testing at their local HTS location by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.

Primary outcomes

  1. Number of participants testing for the first time

    Time frame: 1 year

    Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants choosing to get HIV tested for the first time.

  2. Number of newly diagnosed HIV-infected or known positive and not in care

    Time frame: 1 year

    Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants newly being diagnosed with HIV after participation, or those known to be positive but not currently under care.

  3. Linking a new positive or known positive not in care to a treatment center

    Time frame: 1 year

    Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that are linked to care at a treatment center.

  4. Initiating ART, or re-initiating ART if previously lost to follow-up

    Time frame: 1 year

    Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that initiate (or re-initiate) ART.

Secondary outcomes

  1. Difficulty of using the HIVST kit

    Time frame: 1 year

    Understand the ease of using HIV self-testing kits in this population and setting, via a survey question with a 4 point Likert scale ranging from "very easy" to "very "hard".

  2. Difficulty of interpreting the HIVST results

    Time frame: 1 year

    Understand the readability of HIV self-testing results in this population and setting, via a survey question.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenyatta National Hospital
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Nairobi

Registry information

Official study title

Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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