NCT00390949

Brief Summary

The purpose of this study is to determine whether community-based peer education and condom distribution combined with improved treatment of sexually transmitted infections are effective in reducing the spread of HIV infection in a sub-Saharan African population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,454

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jul 1998

Longer than P75 for not_applicable hiv-infections

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

July 1, 1998

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
12.9 years until next milestone

Results Posted

Study results publicly available

August 29, 2019

Completed
Last Updated

November 22, 2024

Status Verified

October 1, 2024

Enrollment Period

4.6 years

First QC Date

October 20, 2006

Results QC Date

May 11, 2019

Last Update Submit

October 6, 2024

Conditions

HIV Infections

Keywords

HIV preventionZimbabweCore groupsPeer educationSyndromic managementCommercial sex workersCondom distributionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • HIV Incidence at the Community Level

    Number of new infections occurring per 100 person-years of follow-up

    3 years

Secondary Outcomes (6)

  • Self-reported Genital Ulcers

    1 year

  • Self-reported Urethral or Genital Discharge

    1 year

  • Percentage of Participants Reporting Cessation of Sexually Transmitted Infection Symptoms

    1 year

  • Percentage of Participants Reporting More Than One Casual Partner in the Past 3 Years

    3 years

  • Percentage of Participants Attending a Peer Education or Other Programme Meeting

    3 years

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities

Behavioral: Peer education among commercial sex workers and clientsBehavioral: Condom distribution and promotionProcedure: Syndromic treatment of sexually transmitted infectionsProcedure: Systemic counselling for STI patients

Control

NO INTERVENTION

Standard of care

Interventions

Peer education among commercial sex workers and clientsBEHAVIORAL
Intervention arm
Condom distribution and promotionBEHAVIORAL
Intervention arm
Syndromic treatment of sexually transmitted infectionsPROCEDURE
Intervention arm
Systemic counselling for STI patientsPROCEDURE
Intervention arm

Eligibility Criteria

Age15 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: Males aged 17-54 years; females aged 15-44 years at last birthday Residence: Slept in a household in the study areas on at least 4 nights in the last 30 days

You may not qualify if:

  • Age: Males below the age of 17 years at last birthday or aged 55 years or above; females below the age of 15 years at last birthday or aged 45 years or above Residence: Did not sleep in a household in the study areas on at least 4 nights in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Research and Training Institute

Harare, Zimbabwe

Location

Related Publications (2)

  • Campbell C, Scott K, Mupambireyi Z, Nhamo M, Nyamukapa C, Skovdal M, Gregson S. Community resistance to a peer education programme in Zimbabwe. BMC Health Serv Res. 2014 Nov 19;14:574. doi: 10.1186/s12913-014-0574-5.

    PMID: 25407818BACKGROUND

  • Gregson S, Garnett GP, Nyamukapa CA, Hallett TB, Lewis JJ, Mason PR, Chandiwana SK, Anderson RM. HIV decline associated with behavior change in eastern Zimbabwe. Science. 2006 Feb 3;311(5761):664-6. doi: 10.1126/science.1121054.

    PMID: 16456081RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Limitations and Caveats

The study was conducted at the peak of a large HIV epidemic during a period of high inflation and the results might not be generalizable to other epidemiological or structural conditions.

Results Point of Contact

Title
Professor Simon Gregson
Organization
Imperial College London
Sajgregson@aol.com
+4402075943279

Study Officials

  • Simon Gregson, DPhil

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Stephen Chandiwana, PhD

    Biomedical Research and Training Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Demography and Behavioural Science

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 23, 2006

Study Start

July 1, 1998

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

November 22, 2024

Results First Posted

August 29, 2019

Record last verified: 2024-10

Locations

ZI(1)