Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248469
Status:
COMPLETED
Last Update Posted:
2006-10-20
First Post:
2005-11-02
Brief Title:
MEMA Kwa Vijana Trial Impact of an Adolescent Sexual and Reproductive Health Intervention in Mwanza Tanzania
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania MEMA Kwa Vijana Trial
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10000 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 9445 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 9645 adolescents mean age 155 years 95 range 141-183 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 076 95CI 035165 Overall prevalences of HSV2 were 119 in males and 211 in females with adjusted prevalence ratios PRs of 092 95CI069122 and 105 95CI083132 respectively There was no consistent impact on the other biological outcomes with adjusted PRs varying from 078 95CI046130 for syphilis in males to 194 95CI101372 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
Methods Using data from a prior population-based survey of 9445 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 9645 adolescents mean age 155 years 95 range 141-183 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 076 95CI 035165 Overall prevalences of HSV2 were 119 in males and 211 in females with adjusted prevalence ratios PRs of 092 95CI069122 and 105 95CI083132 respectively There was no consistent impact on the other biological outcomes with adjusted PRs varying from 078 95CI046130 for syphilis in males to 194 95CI101372 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None