Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
European Commission
Development Cooperation Ireland (previously known as Ireland Aid)
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00248469
First received: November 2, 2005
Last updated: October 19, 2006
Last verified: November 2005

November 2, 2005
October 19, 2006
July 1998
Not Provided
  • HIV-1 seroincidence
  • HSV2 seroprevalence
  • * HIV-1 seroincidence
  • * HSV2 seroprevalence
Complete list of historical versions of study NCT00248469 on ClinicalTrials.gov Archive Site
  • 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
  • * 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
Not Provided
Not Provided
 
MEMA Kwa Vijana Trial: Impact of an Adolescent Sexual and Reproductive Health Intervention in Mwanza, Tanzania
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Diseases
  • Pregnancy
  • Sexual Behavior
  • Behavioral: In-school Sexual Health Education
  • Behavioral: Youth-friendly health services
  • Behavioral: Youth condom promotion & distribution
  • Behavioral: Community activities related to adolescent sexual health
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
April 2002
Not Provided

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

Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00248469
MkV1: ITIDRD90
Not Provided
Not Provided
London School of Hygiene and Tropical Medicine
  • European Commission
  • Development Cooperation Ireland (previously known as Ireland Aid)
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
London School of Hygiene and Tropical Medicine
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP