NCT06176859

Brief Summary

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

April 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

April 22, 2023

Last Update Submit

January 9, 2026

Conditions

HIVARTHuman Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) .

    The proportion of study participants who effectively accessed PrEP and continued use over a 12-month period.

    36 Months

Secondary Outcomes (3)

  • The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation.

    36 Months

  • Persistent use of PrEP over a 12-month period.

    36 Months

  • Cost effectiveness per HIV incident averted.

    36 Months

Study Arms (2)

Home-based PrEP

EXPERIMENTAL

In the home-based PrEP arm, participants will complete the HIV self-test at home with support received through telemedicine or over the phone. Confirmation of HIV test result will be shared with the provider through a photograph of the test. PrEP refills will be delivered to participants at home by courier.

Other: HIV PrEP Delivery

Community-based PrEP

ACTIVE COMPARATOR

In the community-based PrEP arm, participants will be tested using rapid diagnostic tests (RDT) in person (at a community venue) or through telemedicine (at a community venue) where they will be linked by counsellor telephonically to nurse or clinician. PrEP refills will be collected by participants at a community venue.

Other: HIV PrEP Delivery

Interventions

HIV PrEP DeliveryOTHER

To test an end-to-end decentralized delivery service for pre-exposure prophylaxis (PrEP) to safely increase PrEP access and use among priority populations in South Africa.

Community-based PrEPHome-based PrEP

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 16 years - 30 years old,
  • Self-report living without HIV or unknown status.
  • Persons who have been sexually active within the last 3 months
  • Interested in the use of PrEP for HIV prevention.
  • Able and willing to provide informed consent for study procedures.
  • Access to a cellphone for study related communication
  • Reside in the study community for the duration of follow-up.

You may not qualify if:

  • HIV infection based on negative HIV rapid tests
  • Clinically ineligible for PrEP
  • The participant doesn't reside in the study community for the duration of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Sciences Research Council

Durban, KwaZulu-Natal, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Zaynab Essack, PhD

    Human Sciences Research Council of South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A prospective, interventional, and randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2023

First Posted

December 20, 2023

Study Start

July 17, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

ZA(1)