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

NCT02735642 | Completed Results

• 2 other identifiers: 15120169851R01AI122797
• Study Type: interventional
• Target: 1,198
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV

  Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV.

  Baseline

Secondary Outcomes (1)

• SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.

  Baseline to about 6 weeks

Study Arms (6)

SMART Randomization 1 - Referral

EXPERIMENTAL

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

SMART Randomization 1 - Referral and SMS

EXPERIMENTAL

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

SMART Randomization 2 - SMS

EXPERIMENTAL

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

SMART Randomization 2 - Incentive

EXPERIMENTAL

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

High Risk Negative Cohort (N=185)

OTHER

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)

All participants. Approximately (N=1200)

OTHER

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)

Interventions

SMART Randomization 1 - Referral BEHAVIORAL

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.

SMART Randomization 1 - Referral

SMART Randomization 1 - Referral and SMS BEHAVIORAL

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.

SMART Randomization 1 - Referral and SMS

SMART Randomization 2 - SMS BEHAVIORAL

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.

SMART Randomization 2 - SMS

SMART Randomization 2 - Incentive BEHAVIORAL

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.

SMART Randomization 2 - Incentive

High Risk Negative Cohort (N=185) BEHAVIORAL

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.

High Risk Negative Cohort (N=185)

All participants. Approximately (N=1200) OTHER

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.

All participants. Approximately (N=1200)

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Kenyatta National Hospital: collaborator
• Impact Research & Development Organization: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Impact Research & Development Organization

Kisumu, Kenya

Location

Related Publications (2)

• Inwani I, Chhun N, Agot K, Cleland CM, Buttolph J, Thirumurthy H, Kurth AE. High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority Population. JMIR Res Protoc. 2017 Dec 13;6(12):e179. doi: 10.2196/resprot.8200.

  PMID: 29237583 BACKGROUND

• Inwani I, Chhun N, Agot K, Cleland CM, Rao SO, Nduati R, Kinuthia J, Kurth AE. Preferred HIV Testing Modalities Among Adolescent Girls and Young Women in Kenya. J Adolesc Health. 2021 Mar;68(3):497-507. doi: 10.1016/j.jadohealth.2020.07.007. Epub 2020 Aug 11.

  PMID: 32792256 RESULT

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Ann Kurth
• Organization: Yale University School of Nursing

ann.kurth@yale.edu

N/A

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We utilized an approach called permuted blocks randomization for participant assignment to the SMART trial linkage to care intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive linkage to care interventions for newly diagnosed HIV-positive participants. Total N recruited will depend on HIV prevalence found in the study.

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 13, 2016
• Study Start: May 15, 2017
• Primary Completion: April 10, 2018
• Study Completion: June 30, 2019
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)