Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI122797 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kenyatta National Hospital | OTHER_GOV |
| Impact Research & Development Organization | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
|
| 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). |
|
| High Risk Negative Cohort (N=185) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Impact Research & Development Organization | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29237583 | Background | 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. | |
| 32792256 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aim 1: Home-based Recruitment Strategy | In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2016 |
Not provided
Adaptive linkage to care interventions for newly diagnosed HIV-positive participants. Total N recruited will depend on HIV prevalence found in the study.
Not provided
Not provided
We utilized an approach called permuted blocks randomization for participant assignment to the SMART trial linkage to care intervention.
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). |
|
| 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). |
|
|
| 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 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 - 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. |
|
| 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. |
|
| 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. |
|
| Baseline to about 6 weeks |
| FG001 |
| Aim 1: Mobile Event Based Recruitment Strategy |
In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV. |
| COMPLETED |
|
| NOT COMPLETED |
|
This section summarizes the baseline characteristics of our study participants. Therefore N=1198.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex/Gender, Customized | The number of adolescents and young women (AGYW) enrolled via each recruitment strategy. This study only enrolls AGYW. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Baseline to about 6 weeks |
|
Adverse events were collected from the date of first participant enrollment, until the date the last participant completed follow-up (about one year for those who participated in the longitudinal follow-up).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 1,046 | 0 | 1,046 | 1 | 1,046 |
| EG001 | 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). | 0 | 152 | 0 | 152 | 1 | 152 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social Harms | Social circumstances | Systematic Assessment | Social harms are non-medical adverse events that may occur because of being in the study. Socials harms include difficulties in personal relationships, discrimination or stigma from the community or a family members as a result of study participation |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Kurth | Yale University School of Nursing | N/A | ann.kurth@yale.edu |
| Sep 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | SMART Randomization 2 - SMS | Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an SMS message. |
| OG003 | SMART Randomization 2 - Incentive | Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an economic incentive. |
|
|