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

NCT04045912 | Completed Results

• 2 other identifiers: 5R34MH116804R34MH116804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Contraception

Keywords

HIV self-testing; Accredited drug dispensing outlets; Adolescent girls and young women

Outcome Measures

Primary Outcomes (5)

• AGYW Patronage (Count)

  Number of visits by adolescent girls and young women (AGYW) during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months).

  Baseline (pre-randomization) through Month 4

• AGYW Patronage (Proportion)

  Proportion of visits by AGYW during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months); calculated as the number of AGYW customers divided by the total number of customers per observation.

  Baseline (pre-randomization) through Month 4

• HIVST Kit Uptake

  Number of HIV self-test (HIVST) kits distributed to AGYW over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number of HIVST kits distributed to AGYW customers in participating drug shops throughout the implementation period.

  Month 1 (post-randomization) through Month 4

• Contraceptive Distribution

  Number of contraceptives distributed to AGYW, including condoms, oral contraception, and emergency contraception, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of contraceptives distributed to AGYW customers in participating drug shops throughout the implementation period.

  Month 1 (post-randomization) through Month 4

• Health Facility Referrals

  Number of health facility referrals provided to AGYW for sexual and reproductive health (SRH) services, including HIV testing/treatment, family planning, and pregnancy services, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of SRH health facility referrals provided to AGYW customers in participating drug shops throughout the implementation period.

  Month 1 (post-randomization) through Month 4

Secondary Outcomes (1)

• Pregnancy Test Distribution

  Month 1 (post-randomization) through Month 4

Study Arms (2)

HIVST + AGYW-Friendly Services

EXPERIMENTAL

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 discreetly request free SRH products. They will also provide HIV self-test (HIVST) kits to AGYW customers for free.

Other: AGYW-Friendly Services; Other: HIVST

HIVST Only

ACTIVE COMPARATOR

Drug shops in Arm 2 will provide HIVST kits to AGYW customers for free.

Other: HIVST

Interventions

AGYW-Friendly Services OTHER

Drug shops will offer a loyalty program (the "Queen Club") through which AGYW can earn mystery prizes and discreetly 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.

HIVST + AGYW-Friendly Services

HIVST OTHER

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.

HIVST + AGYW-Friendly Services; HIVST Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• Health for a Prosperous Nation: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health, Community Development, Gender, Elderly and Children, Tanzania: collaborator
• RTI International: collaborator

Study Sites (1)

Health for a Prosperous Nation

Shinyanga, Tanzania

Location

Related Publications (2)

• Willard-Grace R, Abigail Cabrera F, Bykhovsky C, Douglas K, Hunter LA, Mnyippembe A, Mgunya KH, McCoy SI, Liu JX. "They call me the 'Great Queen'": implementing the Malkia Klabu program to improve access to HIV self-testing and contraception for adolescent girls and young women in Tanzania. Reprod Health. 2024 Feb 7;21(1):21. doi: 10.1186/s12978-024-01744-x.

  PMID: 38321482 DERIVED

• Hunter LA, Rao A, Napierala S, Kalinjila A, Mnyippembe A, Hassan K, Bertozzi SM, Mfaume R, Njau P, Liu JX, McCoy SI. Reaching Adolescent Girls and Young Women With HIV Self-Testing and Contraception at Girl-Friendly Drug Shops: A Randomized Trial in Tanzania. J Adolesc Health. 2023 Jan;72(1):64-72. doi: 10.1016/j.jadohealth.2022.08.013. Epub 2022 Oct 12.

  PMID: 36241492 DERIVED

Limitations and Caveats

This pilot trial included 10 intervention shops, all located within the specific context in which the intervention was designed. Future studies are needed to evaluate the intervention in other settings. Research assistants conducting shop observations and shopkeepers completing customer logs relied on visual assessment of customer age. There may be measurement error associated with the use of shopkeepers' logs to assess the distribution of SRH products and health facility referrals.

Results Point of Contact

• Title: Dr. Jenny Liu
• Organization: University of California, San Francisco

Jenny.Liu2@ucsf.edu

1-415-502-5200

Study Officials

• Jenny Liu, PhD, MPP, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: July 22, 2019
• Primary Completion: January 7, 2020
• Study Completion: March 11, 2020
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)