NCT00248469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Jul 1998

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
Last Updated

October 20, 2006

Status Verified

November 1, 2005

First QC Date

November 2, 2005

Last Update Submit

October 19, 2006

Conditions

HIV InfectionsSexually Transmitted DiseasesPregnancySexual Behavior

Keywords

Community randomised trialSexual behaviorInterventionEvaluationSexual health educationYouth-friendly health servicesAdolescentsBehavior changeHIV SeronegativityHIV

Outcome Measures

Primary Outcomes (2)

  • HIV-1 seroincidence

  • HSV2 seroprevalence

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Interventions

In-school Sexual Health EducationBEHAVIORAL
Youth-friendly health servicesBEHAVIORAL
Youth condom promotion & distributionBEHAVIORAL
Community activities related to adolescent sexual healthBEHAVIORAL

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \* Parent/guardian and/or young person unable or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanzania National Institute for Medical Research

Mwanza, Mwanza Region, Tanzania

Location

Related Publications (8)

  • 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.

    PMID: 15951245BACKGROUND

  • 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.

    PMID: 14755033RESULT

  • 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.

    PMID: 15189466RESULT

  • 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.

    PMID: 15572640RESULT

  • 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.

    PMID: 11469944RESULT

  • 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.

    PMID: 23805209DERIVED

  • 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.

    PMID: 21931861DERIVED

  • 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.

    PMID: 20543994DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 4, 2005

Study Start

July 1, 1998

Study Completion

April 1, 2002

Last Updated

October 20, 2006

Record last verified: 2005-11

Locations

TA(1)