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
  Purpose

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.


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • HIV-1 seroincidence
  • HSV2 seroprevalence

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 10000
Study Start Date: July 1998
Estimated Study Completion Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248469

Locations
Tanzania
Tanzania National Institute for Medical Research
Mwanza, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00248469     History of Changes
Other Study ID Numbers: MkV1: ITIDRD90
Study First Received: November 2, 2005
Last Updated: October 19, 2006
Health Authority: Tanzania: Food & Drug Administration

Keywords provided by London School of Hygiene and Tropical Medicine:
Community randomised trial
Sexual behavior
Intervention
Evaluation
Sexual health education
Youth-friendly health services
Adolescents
Behavior change
HIV Seronegativity
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014