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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248469
• Other study ID #: MkV1: ITIDRD90
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2005
• Last updated: October 19, 2006
• Start date: July 1998
• Est. completion date: April 2002

Study information

• Verified date: November 2005
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Food & Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: April 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Pregnancy
• Sexual Behavior
• Sexually Transmitted Diseases

Intervention

Behavioral:
• In-school Sexual Health Education

• Youth-friendly health services

• Youth condom promotion & distribution

• Community activities related to adolescent sexual health

Locations

Country	Name	City	State
Tanzania	Tanzania National Institute for Medical Research	Mwanza

Sponsors (3)

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

Country where clinical trial is conducted

Tanzania, 

References & Publications (5)

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. — View 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. — View 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 I — View 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 Tan — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 seroincidence
Primary	HSV2 seroprevalence
Secondary	Syphilis prevalence evaluated in each sex
Secondary	Chlamydia prevalence evaluated in each sex
Secondary	Gonorrhoea prevalence evaluated in each sex
Secondary	Trichomoniasis prevalence evaluated in females
Secondary	Point prevalence of pregnancy by urine pregnancy test evaluated in females
Secondary	Reported incidence of first pregnancy during follow-up evaluated in females
Secondary	Reported sexual debut during follow-up evaluated in each sex
Secondary	Reported multiple sexual partners during the past year evaluated in each sex
Secondary	Reported initiation of condom use during follow-up evaluated in each sex
Secondary	Reported use of a condom at last sexual intercourse evaluated in each sex
Secondary	Reported attendance at a health facility among those who had experienced STI symptoms evaluated in each sex
Secondary	Knowledge score for HIV based on the answers to three questions evaluated evaluated in each sex
Secondary	Knowledge score for STI based on the answers to three questions evaluated evaluated in each sex
Secondary	Knowledge score for Pregnancy based on the answers to three questions evaluated evaluated in each sex
Secondary	Attitude score for Sexual & Reproductive Health issues based on the answers to three questions evaluated evaluated in each sex