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

NCT ID: NCT02735642

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2019-06-30

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.

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.

Conditions

HIV; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

SMART Randomization 1 - Referral

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

SMART Randomization 1 - Referral and SMS

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

SMART Randomization 2 - SMS

Intervention Type: 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 - 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).

Group Type: EXPERIMENTAL

SMART Randomization 2 - Incentive

Intervention Type: 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.

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).

Group Type: OTHER

High Risk Negative Cohort (N=185)

Intervention Type: 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.

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).

Group Type: OTHER

All participants. Approximately (N=1200)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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

• Resides outside of Homa Bay County
• HIV positive
• If under 18 and not an emancipated minor, unable to get parental consent

Exclusion Criteria

• Male
• Unable to understand spoken English, or Kiswahili or Dholuo

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kenyatta National Hospital

OTHER_GOV

Sponsor Role: collaborator

Impact Research & Development Organization

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann E. Kurth, PhD, CNM

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Irene Inwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kenyatta National Hospital

Kawango Agot, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Impact Research & Development Organization

Locations

Impact Research & Development Organization

Kisumu, , Kenya

Countries

Kenya

References

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.

Reference Type: BACKGROUND

PMID: 29237583 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32792256 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01AI122797

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1512016985

Identifier Type: -

Identifier Source: org_study_id