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

Primary Purpose

HIV Infections, Sexually Transmitted Diseases, Pregnancy

Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
In-school Sexual Health Education
Youth-friendly health services
Youth condom promotion & distribution
Community activities related to adolescent sexual health
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Community randomised trial, Sexual behavior, Intervention, Evaluation, Sexual health education, Youth-friendly health services, Adolescents, Behavior change, HIV Seronegativity, HIV

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tanzania National Institute for Medical Research

Outcomes

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

Full Information

First Posted
November 2, 2005
Last Updated
October 19, 2006
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
European Commission, Development Cooperation Ireland (previously known as Ireland Aid)
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1. Study Identification

Unique Protocol Identification Number
NCT00248469
Brief Title
MEMA Kwa Vijana Trial: Impact of an Adolescent Sexual and Reproductive Health Intervention in Mwanza, Tanzania
Official Title
Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
European Commission, Development Cooperation Ireland (previously known as Ireland Aid)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases, Pregnancy, Sexual Behavior
Keywords
Community randomised trial, Sexual behavior, Intervention, Evaluation, Sexual health education, Youth-friendly health services, Adolescents, Behavior change, HIV Seronegativity, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
In-school Sexual Health Education
Intervention Type
Behavioral
Intervention Name(s)
Youth-friendly health services
Intervention Type
Behavioral
Intervention Name(s)
Youth condom promotion & distribution
Intervention Type
Behavioral
Intervention Name(s)
Community activities related to adolescent sexual health
Primary Outcome Measure Information:
Title
HIV-1 seroincidence
Title
HSV2 seroprevalence
Secondary Outcome Measure Information:
Title
Syphilis prevalence evaluated in each sex
Title
Chlamydia prevalence evaluated in each sex
Title
Gonorrhoea prevalence evaluated in each sex
Title
Trichomoniasis prevalence evaluated in females
Title
Point prevalence of pregnancy by urine pregnancy test evaluated in females
Title
Reported incidence of first pregnancy during follow-up evaluated in females
Title
Reported sexual debut during follow-up evaluated in each sex
Title
Reported multiple sexual partners during the past year evaluated in each sex
Title
Reported initiation of condom use during follow-up evaluated in each sex
Title
Reported use of a condom at last sexual intercourse evaluated in each sex
Title
Reported attendance at a health facility among those who had experienced STI symptoms evaluated in each sex
Title
Knowledge score for HIV based on the answers to three questions evaluated evaluated in each sex
Title
Knowledge score for STI based on the answers to three questions evaluated evaluated in each sex
Title
Knowledge score for Pregnancy based on the answers to three questions evaluated evaluated in each sex
Title
Attitude score for Sexual & Reproductive Health issues based on the answers to three questions evaluated evaluated in each sex

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Ross, BMBCh, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard J Hayes, DSc
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David C Mabey, MD, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M Changalucha, MSc
Organizational Affiliation
Tanzania National Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanzania National Institute for Medical Research
City
Mwanza
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
15951245
Citation
Hayes RJ, Changalucha J, Ross DA, Gavyole A, Todd J, Obasi AI, Plummer ML, Wight D, Mabey DC, Grosskurth H. The MEMA kwa Vijana project: design of a community randomised trial of an innovative adolescent sexual health intervention in rural Tanzania. Contemp Clin Trials. 2005 Aug;26(4):430-42. doi: 10.1016/j.cct.2005.04.006.
Results Reference
background
PubMed Identifier
14755033
Citation
Todd J, Changalucha J, Ross DA, Mosha F, Obasi AI, Plummer M, Balira R, Grosskurth H, Mabey DC, Hayes R. The sexual health of pupils in years 4 to 6 of primary schools in rural Tanzania. Sex Transm Infect. 2004 Feb;80(1):35-42. doi: 10.1136/sti.2003.005413.
Results Reference
result
PubMed Identifier
15189466
Citation
Plummer ML, Wight D, Ross DA, Balira R, Anemona A, Todd J, Salamba Z, Obasi AI, Grosskurth H, Changalunga J, Hayes RJ. Asking semi-literate adolescents about sexual behaviour: the validity of assisted self-completion questionnaire (ASCQ) data in rural Tanzania. Trop Med Int Health. 2004 Jun;9(6):737-54. doi: 10.1111/j.1365-3156.2004.01254.x.
Results Reference
result
PubMed Identifier
15572640
Citation
Plummer ML, Ross DA, Wight D, Changalucha J, Mshana G, Wamoyi J, Todd J, Anemona A, Mosha FF, Obasi AI, Hayes RJ. "A bit more truthful": the validity of adolescent sexual behaviour data collected in rural northern Tanzania using five methods. Sex Transm Infect. 2004 Dec;80 Suppl 2(Suppl 2):ii49-56. doi: 10.1136/sti.2004.011924.
Results Reference
result
PubMed Identifier
11469944
Citation
Obasi AI, Balira R, Todd J, Ross DA, Changalucha J, Mosha F, Grosskurth H, Peeling R, Mabey DC, Hayes RJ. Prevalence of HIV and Chlamydia trachomatis infection in 15--19-year olds in rural Tanzania. Trop Med Int Health. 2001 Jul;6(7):517-25. doi: 10.1046/j.1365-3156.2001.00738.x.
Results Reference
result
PubMed Identifier
23805209
Citation
Lemme F, Doyle AM, Changalucha J, Andreasen A, Baisley K, Maganja K, Watson-Jones D, Kapiga S, Hayes RJ, Ross DA. HIV Infection among Young People in Northwest Tanzania: The Role of Biological, Behavioural and Socio-Demographic Risk Factors. PLoS One. 2013 Jun 21;8(6):e66287. doi: 10.1371/journal.pone.0066287. Print 2013.
Results Reference
derived
PubMed Identifier
21931861
Citation
Doyle AM, Weiss HA, Maganja K, Kapiga S, McCormack S, Watson-Jones D, Changalucha J, Hayes RJ, Ross DA. The long-term impact of the MEMA kwa Vijana adolescent sexual and reproductive health intervention: effect of dose and time since intervention exposure. PLoS One. 2011;6(9):e24866. doi: 10.1371/journal.pone.0024866. Epub 2011 Sep 13.
Results Reference
derived
PubMed Identifier
20543994
Citation
Doyle AM, Ross DA, Maganja K, Baisley K, Masesa C, Andreasen A, Plummer ML, Obasi AI, Weiss HA, Kapiga S, Watson-Jones D, Changalucha J, Hayes RJ; MEMA kwa Vijana Trial Study Group. Long-term biological and behavioural impact of an adolescent sexual health intervention in Tanzania: follow-up survey of the community-based MEMA kwa Vijana Trial. PLoS Med. 2010 Jun 8;7(6):e1000287. doi: 10.1371/journal.pmed.1000287.
Results Reference
derived

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

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