HIVGIRLSNCT02735642
High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya
A study testing SMART Randomization 1 - Referral, SMART Randomization 1 - Referral and SMS and SMART Randomization 2 - SMS in people with HIV and Adolescent Behavior, run by Yale University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Adolescent Behavior
- What is being tested?
- SMART Randomization 1 - Referral, SMART Randomization 1 - Referral and SMS and SMART Randomization 2 - SMS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,198 participants
- Where
- 1 siteKenya
- Study dates
- 15 May 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
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.
Read the 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
- Being tested
- SMART Randomization 1 - Referral, SMART Randomization 1 - Referral and SMS, SMART Randomization 2 - SMS, SMART Randomization 2 - Incentive, High Risk Negative Cohort (N=185)
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Randomization 1 - ReferralBehavioural
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 SMSBehavioural
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 - SMSBehavioural
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 - IncentiveBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: All participants. Approximately (N=1200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline to about 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start15 May 2017
- Primary completion10 Apr 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, Impact Research & Development Organization, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Ann E. Kurth, PhD, CNM, Principal investigator, Yale University School of NursingIrene Inwani, MD, MPH, Principal investigator, Kenyatta National HospitalKawango Agot, PhD, MPH, Principal investigator, Impact Research & Development Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735642
- Sponsor's protocol ID
- 1512016985
- Other IDs
- 1R01AI122797
- Acronym
- GIRLS
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2016
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29237583Inwani 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.
PubMed 32792256
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
- ClinicalTrials.gov ID
- NCT02735642
- Acronym / sponsor ID
- GIRLS / 1512016985
- Conditions
- HIV, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,198 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, Impact Research & Development Organization, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| SMART Randomization 1 - Referral | Experimental | Behavioral: SMART Randomization 1 - ReferralParticipants 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 | Behavioral: SMART Randomization 1 - Referral and SMSParticipants 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 | Behavioral: SMART Randomization 2 - SMSHIV 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 | Behavioral: SMART Randomization 2 - IncentiveHIV 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) | Other | 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). |
| All participants. Approximately (N=1200) | Other | Other: 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). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART Randomization 1 - ReferralParticipants 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. | Behavioural | SMART Randomization 1 - Referral |
| SMART Randomization 1 - Referral and SMSParticipants 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. | Behavioural | SMART Randomization 1 - Referral and SMS |
| SMART Randomization 2 - SMSThose 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. | Behavioural | SMART Randomization 2 - SMS |
| SMART Randomization 2 - IncentiveThose 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. | Behavioural | SMART Randomization 2 - Incentive |
| 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. | Behavioural | High Risk Negative Cohort (N=185) |
| 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. | Other | All participants. Approximately (N=1200) |
Primary outcome
Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV
Time frame: 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.
1 secondary outcome
SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.
Time frame: Baseline to about 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29237583Inwani 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.
- Results publication: PubMed 32792256Inwani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann E. Kurth, PhD, CNM principal investigator
Yale University School of Nursing
Irene Inwani, MD, MPH principal investigator
Kenyatta National Hospital
Kawango Agot, PhD, MPH principal investigator
Impact Research & Development Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Randomization 1 - Referral, SMART Randomization 1 - Referral and SMS and SMART Randomization 2 - SMS in people with HIV and Adolescent Behavior, run by Yale University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.