NCT04048551

Brief Summary

The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Specifically, this project aims to: increase uptake, of sexual and reproductive health (SRH) services and readiness and uptake of PrEP among adolescent girls and young women (AGYW) aged 16 to 24 who engage in high-risk sexual behaviors; and reduce their barriers to accessing SRH services by addressing and reducing stigma and discrimination (S\&D) in clinics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.2 years

First QC Date

May 28, 2019

Last Update Submit

January 6, 2025

Conditions

HIV Prevention

Keywords

PrEP (Pre-exposure Prophylaxis)HIV (Human Immunodeficiency Virus)Adolescent Girls and Young Women (AGYW)Stigma and Discrimination (S&D)Gender-based violence (GBV)Substance use

Outcome Measures

Primary Outcomes (19)

  • Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

    Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.

    Baseline

  • Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

    Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.

    4 months

  • Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

    Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.

    8 months

  • Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

    A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.

    Baseline

  • Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

    A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.

    4 months

  • Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

    A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.

    8 months

  • AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

    Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures developed for this study and from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.

    Baseline

  • AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

    Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.

    3 months

  • AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

    Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.

    6 months

  • AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

    Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.

    9 months

  • AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW

    Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.

    3 months

  • AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW

    Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.

    6 months

  • AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW

    Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.

    9 months

  • AGYW Biological Outcome: Adherence to PrEP

    Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.

    3 months

  • AGYW Biological Outcome: Adherence to PrEP

    Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.

    6 months

  • AGYW Biological Outcome: Adherence to PrEP

    Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.

    9 months

  • AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW

    Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.

    3 months

  • AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW

    Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.

    6 months

  • AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW

    Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.

    9 months

Secondary Outcomes (53)

  • AGYW Participant Self-Report: Frequency of Drug Use

    Baseline

  • AGYW Participant Self-Report: Frequency of Drug Use

    3 months

  • AGYW Participant Self-Report: Frequency of Drug Use

    6 months

  • AGYW Participant Self-Report: Frequency of Drug Use

    9 months

  • AGYW Participant Self-Report: Frequency of Alcohol Use

    Baseline

  • +48 more secondary outcomes

Study Arms (4)

No S&D Reduction Training; PrEP and SRH only

NO INTERVENTION

Arm 1 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).

No S&D Reduction Training; PrEP and SRH + YWHC

EXPERIMENTAL

Arm 2 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).

Behavioral: Young Women's Health CoOp (YWHC)

S&D Reduction Training; PrEP and SRH only

ACTIVE COMPARATOR

Arm 3 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).

Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum

S&D Reduction Training; PrEP, SRH + YWHC

EXPERIMENTAL

Arm 4 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).

Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumBehavioral: Young Women's Health CoOp (YWHC)

Interventions

Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumBEHAVIORAL

The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.

S&D Reduction Training; PrEP and SRH onlyS&D Reduction Training; PrEP, SRH + YWHC
Young Women's Health CoOp (YWHC)BEHAVIORAL

In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.

No S&D Reduction Training; PrEP and SRH + YWHCS&D Reduction Training; PrEP, SRH + YWHC

Eligibility Criteria

Age16 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV negative
  • identify as female;
  • aged 16-24;
  • have had condomless sex in the past 3 months with a male partner;
  • not be currently pregnant and not want to get pregnant for the next year;
  • interested in taking PrEP;
  • not having previously participated in the formative phase of the study;
  • have not previously and not currently participating in any other PrEP-related demonstration project or research study;
  • not previously or not currently participating in any other HIV study in Tshwane;
  • lives in one of the target communities;
  • not on multidrug-resistant tuberculosis (MDR-TB) treatment;
  • intends to stay in the Tshwane district for the next 12 months;
  • agrees to provide contact information;
  • be willing to undergo rapid HIV testing;
  • be willing to undergo pregnancy testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Setshaba Research Centre

Soshanguve, 0152, South Africa

Location

Related Publications (1)

  • Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Minnis AM, Nyblade L, Speizer IS, Howard BN, Myers B, Ahmed K. The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa. BMC Public Health. 2020 Sep 15;20(1):1403. doi: 10.1186/s12889-020-09458-y.

    PMID: 32933510DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial StigmaSubstance-Related Disorders

Interventions

N-(4'-fluorobutyrophenone)-4-(4-chlorophenyl)pyridinium

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Felicia Browne, ScD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: This is a cluster randomized trial that utilizes a 2 x 2 factorial design to assess the impact of S\&D reduction training and the YWHC intervention, resulting in four study conditions: (1) Clinic S\&D reduction training + PrEP/SRH + YWHC, (2) Clinic S\&D reduction training + PrEP/SRH only, (3) No Clinic S\&D reduction training +PrEP/SRH + YWHC, (4) No Clinic S\&D reduction training + PrEP/SRH only. The researchers will examine two primary endpoints: (1) the proportion of AGYW who are ready to uptake and initiate PrEP and SRH services; and, (2) the differences in levels of PrEP adherence between each intervention condition and the standard of care comparison at 3-, 6- and 9-month follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

August 7, 2019

Study Start

April 4, 2019

Primary Completion

June 23, 2022

Study Completion

June 23, 2022

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)