Adolescent Behavior, HIV
Conditions
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.
Interventions
BEHAVIORALSMART 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.
BEHAVIORALSMART 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.
BEHAVIORALSMART 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.
BEHAVIORALSMART 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.
BEHAVIORALHigh 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.
OTHERAll 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.
Sponsors
Kenyatta National Hospital
Impact Research & Development Organization
National Institute of Allergy and Infectious Diseases (NIAID)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
We utilized an approach called permuted blocks randomization for participant assignment to the SMART trial linkage to care intervention.
Intervention model description
Adaptive linkage to care interventions for newly diagnosed HIV-positive participants. Total N recruited will depend on HIV prevalence found in the study.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV | Baseline | Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. | Baseline to about 6 weeks | After completing HIV testing, newly diagnosed adolescent girls and young women (AGYW) (N=32) participated in an adaptive intervention pilot to figure out the best way to support those newly diagnosed with HIV with initial linkage to care. The SMART trial pilot consisted of two randomizations. In the first randomization, AGYW were assigned to either standard referral (counseling and a referral note) or standard referral plus SMS message; those not linked to care after the first randomization (within a 2-week period) were randomized a second time to receive either a SMS message or financial incentive to link to care. |
Countries
Kenya
Participant flow
Recruitment details
Participants were enrolled between May 2017 and April 2018 from three sites in Homa Bay County, Nyanza region, western Kenya. In fulfillment of Aim 1, we explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
Pre-assignment details
After participants completed HIV testing, only newly diagnosed participants living with HIV were enrolled into the SMART trial component of the study. This occurred from June 2017 to June 2018. Please note these are not additional participants, they are part of the N=1198 enrolled in the overall study.
Participants by arm
| Arm | Count |
|---|---|
| Home-based Recruitment Strategy We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility). | 1,046 |
| Mobile Event Based Recruitment Strategy We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility). | 152 |
| Total | 1,198 |
Baseline characteristics
| Characteristic | Home-based Recruitment Strategy | Mobile Event Based Recruitment Strategy | Total |
|---|---|---|---|
| Age, Continuous | 20 years | 19 years | 20 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1046 Participants | 152 Participants | 1198 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 1046 participants | 152 participants | 1198 participants |
| Sex/Gender, Customized Adolescent girls and young women | 1046 Participants | 152 Participants | 1198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,046 | 0 / 152 |
| other Total, other adverse events | 1 / 1,046 | 1 / 152 |
| serious Total, serious adverse events | 0 / 1,046 | 0 / 152 |
Outcome results
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home-based Recruitment Strategy | Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV | 23 Participants |
| Mobile Event Based Recruitment Strategy | Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV | 9 Participants |
Secondary
SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.
After completing HIV testing, newly diagnosed adolescent girls and young women (AGYW) (N=32) participated in an adaptive intervention pilot to figure out the best way to support those newly diagnosed with HIV with initial linkage to care. The SMART trial pilot consisted of two randomizations. In the first randomization, AGYW were assigned to either standard referral (counseling and a referral note) or standard referral plus SMS message; those not linked to care after the first randomization (within a 2-week period) were randomized a second time to receive either a SMS message or financial incentive to link to care.
Time frame: Baseline to about 6 weeks
Population: Please note our SMART trial is underpowered because HIV prevalence was lower than expected. In the outcome measure data table below, we report the total numbers allocated to each intervention and the number of participants who successfully linked to care.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home-based Recruitment Strategy | SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. | 10 Participants |
| Mobile Event Based Recruitment Strategy | SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. | 10 Participants |
| SMART Randomization 2 - SMS | SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. | 0 Participants |
| SMART Randomization 2 - Incentive | SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. | 1 Participants |