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HIV InfectionsPhase 3NCT00248469

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

A Phase 3 study testing In-school Sexual Health Education, Youth-friendly health services and Youth condom promotion & distribution in people with HIV Infections and Sexually Transmitted Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
What is being tested?
In-school Sexual Health Education, Youth-friendly health services and Youth condom promotion & distribution
How many people
10,000 participants
Where
1 siteTanzania
Study dates
Jul 1998to Apr 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Tanzania National Institute for Medical Research

    Mwanza, Mwanza Region

Other trials in Tanzania

About this study

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

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.

Read the 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.

Being tested
In-school Sexual Health Education, Youth-friendly health services, Youth condom promotion & distribution, Community activities related to adolescent sexual health
Keywords
Community randomised trial, Sexual behavior, Intervention, Evaluation, Sexual health education, Youth-friendly health services, Adolescents, Behavior change, HIV Seronegativity, HIV
Medical subject headings
HIV Infections, Sexually Transmitted Diseases, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-school Sexual Health EducationBehavioural

  • Youth-friendly health servicesBehavioural

  • Youth condom promotion & distributionBehavioural

  • Community activities related to adolescent sexual healthBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-1 seroincidence

  2. HSV2 seroprevalence

Secondary outcomes (15)

  1. Syphilis prevalence evaluated in each sex

  2. Chlamydia prevalence evaluated in each sex

  3. Gonorrhoea prevalence evaluated in each sex

  4. Trichomoniasis prevalence evaluated in females

  5. Point prevalence of pregnancy by urine pregnancy test evaluated in females

  6. Reported incidence of first pregnancy during follow-up evaluated in females

  7. Reported sexual debut during follow-up evaluated in each sex

  8. Reported multiple sexual partners during the past year evaluated in each sex

  9. Reported initiation of condom use during follow-up evaluated in each sex

  10. Reported use of a condom at last sexual intercourse evaluated in each sex

  11. Reported attendance at a health facility among those who had experienced STI symptoms evaluated in each sex

  12. Knowledge score for HIV based on the answers to three questions evaluated evaluated in each sex

  13. Knowledge score for STI based on the answers to three questions evaluated evaluated in each sex

  14. Knowledge score for Pregnancy based on the answers to three questions evaluated evaluated in each sex

  15. Attitude score for Sexual & Reproductive Health issues based on the answers to three questions evaluated evaluated in each sex

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2005 (estimated)
  2. Study startJul 1998
  3. Study completionApr 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248469
Sponsor's protocol ID
MkV1: ITIDRD90
Status last verified
Nov 2005
First submitted
2 Nov 2005
Last updated
20 Oct 2006
Results posted
No

Publications

  • 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.

    PubMed 15951245

  • 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.

    PubMed 14755033

  • 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.

    PubMed 15189466

  • 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.

    PubMed 15572640

  • 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.

    PubMed 11469944

  • 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.

    PubMed 23805209

  • 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.

    PubMed 21931861

  • 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.

    PubMed 20543994

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing In-school Sexual Health Education, Youth-friendly health services and Youth condom promotion & distribution in people with HIV Infections and Sexually Transmitted Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-1 seroincidence. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00248469, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2006.

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