MEMA Kwa Vijana Trial: Impact of an Adolescent Sexual and Reproductive Health Intervention in Mwanza, Tanzania

October 19, 2006 updated by: London School of Hygiene and Tropical Medicine

Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial

The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Adolescents are at high risk of adverse reproductive health outcomes, including HIV, other STIs and unwanted pregnancies. However, there is little empirical evidence to guide the choice and implementation of effective interventions. We assessed the impact of an intervention programme on the sexual health of adolescents in rural Tanzania.

Methods: Using data from a prior population-based survey of 9,445 15-19 year olds, 20 communities were stratified and randomly allocated to either receive the new interventions (Intervention Group) or standard interventions (Comparison Group) during Phase 1 (January 1999-December 2001) of the MEMA kwa Vijana Project. The new intervention programme had four major components: community activities; teacher-led, peer-assisted sex education in the last three years of primary school (Years 5-7); training and supervision of health workers to provide "youth-friendly" STD and family planning services; and peer condom social marketing for youth (from January 2000). The pre-defined primary outcomes were HIV incidence and Herpes simplex virus type 2 (HSV2) in a cohort of 9,645 adolescents, mean age 15.5 years, [95% range 14.1-18.3 years], who were recruited in late 1998 before entering Year 5, 6 or 7 of primary school. Secondary outcomes included six further biomedical, five behavioural, one attitudinal, and three knowledge outcomes.

Findings: At the follow-up survey in late 2001-early 2002, the intervention had had a statistically significant impact on all knowledge and attitudinal outcomes and also on reported condom use and reported STI symptoms in both males and females. Significantly fewer males in the intervention communities reported sexual debut during follow-up, or having multiple sexual partners during the past 12 months, but no difference was seen for these two outcomes among females. There were only five HIV seroconversions in males. Among females, the adjusted rate ratio for HIV incidence (intervention vs comparison communities) was 0.76 (95%CI: 0.35,1.65). Overall prevalences of HSV2 were 11.9% in males and 21.1% in females, with adjusted prevalence ratios (PRs) of 0.92 (95%CI:0.69,1.22) and 1.05 (95%CI:0.83,1.32) respectively. There was no consistent impact on the other biological outcomes, with adjusted PRs varying from 0.78 (95%CI:0.46,1.30) for syphilis in males to 1.94 (95%CI:1.01,3.72) for gonorrhoea in females. A non-significant trend towards greater beneficial impact among students enrolled in Year 4, who potentially received all three years of the in-school programme, was seen for most outcomes. The beneficial impact on knowledge and reported attitudes was confirmed in a cross-sectional survey in a different group of students who were in Year 7 of primary school in mid-2002.

Conclusions: The intervention substantially improved knowledge, reported attitudes and reported condom use in both sexes, and reported sexual behaviour in males, but had no consistent impact on biological outcomes within the three-year trial period. The data suggest a dose-related effect for several outcomes, with greater impact among those receiving two or three years of the in-school programme.

Study Type

Interventional

Enrollment

10000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Mwanza, Tanzania
        • Tanzania National Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 14 years and over on 1st Jan 1999
  • About to enter year 5, 6 or 7 of a primary school in one of the 20 trial communities

Exclusion Criteria:

* Parent/guardian and/or young person unable or unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HIV-1 seroincidence
HSV2 seroprevalence

Secondary Outcome Measures

Outcome Measure
Syphilis prevalence evaluated in each sex
Chlamydia prevalence evaluated in each sex
Gonorrhoea prevalence evaluated in each sex
Trichomoniasis prevalence evaluated in females
Point prevalence of pregnancy by urine pregnancy test evaluated in females
Reported incidence of first pregnancy during follow-up evaluated in females
Reported sexual debut during follow-up evaluated in each sex
Reported multiple sexual partners during the past year evaluated in each sex
Reported initiation of condom use during follow-up evaluated in each sex
Reported use of a condom at last sexual intercourse evaluated in each sex
Reported attendance at a health facility among those who had experienced STI symptoms evaluated in each sex
Knowledge score for HIV based on the answers to three questions evaluated evaluated in each sex
Knowledge score for STI based on the answers to three questions evaluated evaluated in each sex
Knowledge score for Pregnancy based on the answers to three questions evaluated evaluated in each sex
Attitude score for Sexual & Reproductive Health issues based on the answers to three questions evaluated evaluated in each sex

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

European Commission
Development Cooperation Ireland (previously known as Ireland Aid)

Investigators

  • Principal Investigator: David A Ross, BMBCh, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Richard J Hayes, DSC, London School of Hygiene and Tropical Medicine
  • Principal Investigator: David C Mabey, MD, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: John M Changalucha, MSc, Tanzania National Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Completion

April 1, 2002

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria

November 2, 2005

First Posted (Estimate)

November 4, 2005

Study Record Updates

Last Update Posted (Estimate)

October 20, 2006

Last Update Submitted That Met QC Criteria

October 19, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MkV1: ITIDRD90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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