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High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)

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ClinicalTrials.gov Identifier: NCT02735642
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Kenyatta National Hospital
Impact Research & Development Organization
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Yale University

Brief Summary:

Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified HIV-negative young women in reducing HIV risk and adhering to recommended HIV re-testing recommendations. We will also conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention interventions.

Lessons learned will inform Government of Kenya, and other key policymakers, implementing partners and agencies throughout sub-Saharan Africa that are exploring policies about appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for adolescent girls and young women.


Condition or disease Intervention/treatment Phase
HIV Adolescent Behavior Behavioral: SMART Randomization 1 - Referral Behavioral: SMART Randomization 1 - Referral and SMS Behavioral: SMART Randomization 2 - SMS Behavioral: SMART Randomization 2 - Incentive Behavioral: High Risk Negative Cohort (N=185) Other: All participants. Approximately (N=1200) Not Applicable

Detailed Description:

The GIRLS study will inform best practices to increase adolescent girls and young women's uptake of HIV prevention, testing, and linkage for HIV to care services in a high-HIV burden African setting to optimize engagement in both the HIV prevention and care continua.

Aim 1: To determine the preferred recruitment venue and testing modality that targets and finds the highest number of HIV infected and at risk female youth aged 15-24 years in Homa Bay County, Nyanza region, western Kenya.

  • This will be determined by examining the uptake and yield of previously undiagnosed HIV infection of the two (2) 'seek' strategies (community or home-based) and the three (3) 'test' strategies (self-testing, HIV testing services (HTS) in a home/mobile setting, or facility-based HTS) among female youth;

Aim 2: (a) To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive female youth to treatment and care services; and (b) To identify barriers and facilitators to seeking HIV care services after receiving a positive diagnosis; (c) To identify barriers and facilitators to seeking HIV prevention services for high risk female youth after receiving a negative HIV test result; (d) To provide an HIV prevention intervention to a randomly selected subset of high risk negatives, and to re-test them; and

Aim 3: To conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention intervention.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: SMART Randomization 1 - Referral
Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).
Behavioral: SMART Randomization 1 - Referral
Participants will be randomized to receive standard referral to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.

Experimental: SMART Randomization 1 - Referral and SMS
Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).
Behavioral: SMART Randomization 1 - Referral and SMS
Participants will be randomized to receive referral plus SMS to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.

Experimental: SMART Randomization 2 - SMS
HIV positives that have not successfully linked to care after the first randomization will be re-randomized to receive either an SMS message or economic incentive to link to care. (HIV Positive Cohort approximately N=108).
Behavioral: SMART Randomization 2 - SMS
Those that have not linked to care after the first randomization, will be re-randomized to receive an SMS message. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.

Experimental: SMART Randomization 2 - Incentive
HIV positives that have not successfully linked to care after the first randomization will be re-randomized to receive either an SMS message or economic incentive to link to care. (HIV Positive Cohort approximately N=108).
Behavioral: SMART Randomization 2 - Incentive
Those that have not linked to care after the first randomization, will be re-randomized to receive a one-time economic incentive. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.

High Risk Negative Cohort (N=185)
A subset of negatives identified as 'high risk' from the CAPI baseline survey will be invited to participate in the primary prevention intervention (N=185).
Behavioral: High Risk Negative Cohort (N=185)
A subset of negatives identified as 'high risk' from the CAPI baseline survey will be invited to participate in the primary prevention intervention (N=185). They will receive an SMS health promotion message with survey at 6 and 12 months. At 12 months, they will be re-tested for HIV and an exit interview completed.

All participants. Approximately (N=1200)
HIV testing options that female youth can choose from include: (1) oral fluid HIV self-testing (OHIVST) at their convenience; (2) immediate staff-aided testing at home/mobile site; and (3) a referral to a health care facility where HIV testing will be done by a health care provider (standard facility-based HTS).
Other: All participants. Approximately (N=1200)

HIV testing approaches that females can choose from include: (1) oral fluid HIV self-testing (OHIVST) at their convenience; (2) immediate staff-aided testing at home/mobile site; and (3) a referral to a health care facility where HIV testing will be done by a health care provider (standard facility-based HTS).

All participants will receive a behavioral CAPI survey at baseline visit, an SMS HIV test experience satisfaction survey, and for those who choose the self-testing option, a staff-administered questionnaire.





Primary Outcome Measures :
  1. Primary Outcome: Newly diagnosed HIV infection [ Time Frame: Baseline ]
    Previously undiagnosed HIV infection

  2. Other Aim 1 outcomes: Uptake of recruitment strategies 1 [ Time Frame: Baseline ]
    Proportion of females who accept study screening via each recruitment strategy (home-based vs. community based recruitment).

  3. Other Aim 1 Outcomes: Uptake of recruitment strategies 2 [ Time Frame: Baseline ]
    Proportion of females who accept study enrollment (home-based vs. community based recruitment).

  4. Other Aim 1 outcomes: Uptake of different testing modalities [ Time Frame: Baseline ]
    Proportion who choose to test via: (a) oral fluid HIV self-testing (OHIVST) at their convenience; (b) immediate staff-aided testing at home/mobile site; and (c) a referral to a health care facility where HIV testing will be done by a health care provider (standard facility-based HTS).

  5. Other Aim 1 Outcomes: testing 1 [ Time Frame: Baseline ]
    Proportion that are HIV-positive

  6. Other outcomes: testing 2 [ Time Frame: Baseline ]
    Proportion of high-risk HIV-negative identified


Secondary Outcome Measures :
  1. Linkage to care 1 [ Time Frame: Baseline to approximately 1 month ]
    Percent of females who tested positive that attended a first HIV care appointment at an HIV Comprehensive Care Center (CCC)

  2. Linkage to care 2 [ Time Frame: Baseline to approximately 1 month ]
    Time to link to care after positive confirmatory test result

  3. Retention in care 1 [ Time Frame: 3 months ]
    Reported appointment attendance via SMS and verification by study staff

  4. Retention in care 2 [ Time Frame: 6 months ]
    Reported appointment attendance via SMS and verification by study staff

  5. Retention in care 3 [ Time Frame: 9 months ]
    Reported appointment attendance via SMS and verification by study staff

  6. Retention in care 4 [ Time Frame: 12 months ]
    Reported appointment attendance via SMS and verification by study staff

  7. Retention in care 5 [ Time Frame: 12 months ]
    Completion of viral load testing

  8. Primary prevention 1 [ Time Frame: 6 months ]
    Proportion reporting HIV risk behaviors, and condom use

  9. Primary prevention 2 [ Time Frame: 12 months ]
    Proportion reporting HIV risk behaviors, and condom use

  10. Primary prevention 3 [ Time Frame: 12 months ]
    Proportion who re-tested at 12 months

  11. Primary prevention 4 [ Time Frame: 12 months ]
    Proportion who tested positive at 12 months


Other Outcome Measures:
  1. Economic Evaluation: Key outcome 1 [ Time Frame: Baseline to approximately 1 month ]
    Incremental cost per HIV-positive female identified

  2. Economic Evaluation: Key outcome 2 [ Time Frame: Baseline to approximately 1 month ]
    Incremental cost per HIV-positive female linked to care



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to understand spoken English or Kiswahili or Dholuo
  • Resides in Homa Bay County
  • Not previously diagnosed as HIV positive
  • Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent

Exclusion Criteria:

  • Male
  • Unable to understand spoken English, or Kiswahili or Dholuo
  • Females who do not meet age inclusion criteria
  • Resides outside of Homa Bay County
  • HIV positive
  • If under 18 and not an emancipated minor, unable to get parental consent

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): NCT02735642


Contacts
Contact: Nok Chhun, MS, MPH 203-737-4948 nok.chhun@yale.edu
Contact: Ann E. Kurth, PhD, CNM 203-785-2393 ann.kurth@yale.edu

Locations
Kenya
Impact Research & Development Organization Recruiting
Kisumu, Kenya
Contact: Samwel Rao, MPH    +254 713 687 399    samwel.rao@impact-rdo.org   
Contact: Kawango Agot, PhD, MPH       mamagifto@yahoo.com   
Sponsors and Collaborators
Yale University
Kenyatta National Hospital
Impact Research & Development Organization
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Ann E. Kurth, PhD, CNM Yale University School of Nursing
Principal Investigator: Irene Inwani, MD, MPH Kenyatta National Hospital
Principal Investigator: Kawango Agot, PhD, MPH Impact Research & Development Organization

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02735642     History of Changes
Other Study ID Numbers: 1512016985
1R01AI122797 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No