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Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045912
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
University of California, Berkeley
Health for a Prosperous Nation
National Institute of Mental Health (NIMH)
Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
RTI International
Information provided by (Responsible Party):
Jenny Liu, PhD, MPP, University of California, San Francisco

Brief Summary:
We will pilot an intervention to deliver sexual and reproductive health services, including HIV self-testing (HIVST) and contraception, to adolescent girls and young women (AGYW) at accredited drug dispensing outlets (ADDOs) in Shinyanga, Tanzania. In a 4-month randomized pilot study, we will compare mediating outcomes (AGYW patronage, product distribution, and referral) between 10 intervention and 10 comparison ADDOs, using data from time-location surveys of customers and inventory distribution and referral records.

Condition or disease Intervention/treatment Phase
HIV Contraception Other: AGYW-Friendly Services Other: HIVST Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIVST + AGYW-Friendly Services
Drug shops in Arm 1 will implement AGYW-friendly services, including a sexual and reproductive health (SRH) product display, a tablet with SRH videos, and a loyalty program ("the Queen Club") through which AGYW can earn mystery prizes and discretely request free SRH products. They will also provide HIV self-test (HIVST) kits to AGYW customers for free.
Other: AGYW-Friendly Services
Drug shops will offer a loyalty program (the "Queen Club") through which AGYW can earn mystery prizes and discretely request free SRH products. Drug shops will also have an SRH product display and a tablet with SRH videos for interested customers, and drug shop employees will receive training on contraceptive counseling for AGYW.

Other: HIVST
Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.

Active Comparator: HIVST Only
Drug shops in Arm 2 will provide HIVST kits to AGYW customers for free.
Other: HIVST
Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.




Primary Outcome Measures :
  1. AGYW patronage [ Time Frame: Baseline through Month 4 ]
    Number and proportion of visits by AGYW at baseline (up to 1 month prior to intervention) and during the final 2 months of the intervention.

  2. Contraceptive distribution [ Time Frame: Baseline through Month 4 ]
    Number and types of contraceptives (i.e., condoms, oral contraception, emergency contraception) distributed to AGYW per month.

  3. Health facility referrals [ Time Frame: Baseline through Month 4 ]
    Number of referrals for AGYW made for sexual and reproductive health services, including family planning, prenatal, and HIV testing/treatment services.

  4. HIVST kit uptake [ Time Frame: Baseline through Month 4 ]
    Number and proportion of kits distributed to AGYW per month.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age;
  • Owns an accredited drug dispensing outlet (ADDO);
  • Willing to offer HIVST and AGYW-friendly services at drug shop;
  • Provides written informed consent for the study.

Exclusion Criteria:

  • Less than 18 years of age;
  • Owns a drug shop that is not accredited;
  • Unwilling to offer HIVST and/or AGYW-friendly services at drug shop;
  • Does not provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045912


Contacts
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Contact: Jenny Liu, PhD, MPP, MA +1 415 502 5200 Jenny.Liu2@ucsf.edu
Contact: Sandra I McCoy, PhD, MPH +1 510 642 0513 smccoy@berkeley.edu

Locations
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Tanzania
Health for a Prosperous Nation Recruiting
Shinyanga, Tanzania
Contact: Sandra I McCoy, PhD, MPH    +1 510 642 0513    smccoy@berkeley.edu   
Contact: Prosper Njau, MD, MPH    +255 784 597 929    prosperpendo@gmail.com   
Principal Investigator: Jenny Liu, PhD, MPP, MA         
Principal Investigator: Sandra I McCoy, PhD, MPH         
Sponsors and Collaborators
University of California, San Francisco
University of California, Berkeley
Health for a Prosperous Nation
National Institute of Mental Health (NIMH)
Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
RTI International

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Responsible Party: Jenny Liu, PhD, MPP, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04045912    
Other Study ID Numbers: 5R34MH116804 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jenny Liu, PhD, MPP, University of California, San Francisco:
HIV self-testing
Accredited drug dispensing outlets
Adolescent girls and young women