NCT00067522

Brief Summary

Prevention of unplanned pregnancies among HIV infected couples decreases the rate of maternal-child virus transmission and the number of children orphaned when parents die of AIDS. This study will evaluate two programs for reducing the number of unplanned pregnancies among HIV infected couples in Zambia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2003

Completed
Last Updated

June 29, 2007

Status Verified

September 1, 2005

First QC Date

August 21, 2003

Last Update Submit

June 28, 2007

Conditions

Keywords

Family PlanningSexually Transmitted DiseasesHIVAfricaZambiaAIDSContraceptionHIV Prevention

Outcome Measures

Primary Outcomes (1)

  • pregnancy

Interventions

Eligibility Criteria

Age16 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Couples with one or both partners with HIV infection

You may not qualify if:

  • Pregnant or \< 1 month post-partum (couples will be invited to return when the infant is \> 1 month old)
  • Peri- or post-menopausal
  • Surgical sterilization or hysterectomy
  • Documented infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zambia Emory HIV Research Project

Lusaka, Zambia

Location

Related Publications (3)

  • Wall KM, Haddad L, Vwalika B, Htee Khu N, Brill I, Kilembe W, Stephenson R, Chomba E, Vwalika C, Tichacek A, Allen S. Unintended pregnancy among HIV positive couples receiving integrated HIV counseling, testing, and family planning services in Zambia. PLoS One. 2013 Sep 30;8(9):e75353. doi: 10.1371/journal.pone.0075353. eCollection 2013.

  • Haddad L, Wall KM, Vwalika B, Khu NH, Brill I, Kilembe W, Stephenson R, Chomba E, Vwalika C, Tichacek A, Allen S. Contraceptive discontinuation and switching among couples receiving integrated HIV and family planning services in Lusaka, Zambia. AIDS. 2013 Oct;27 Suppl 1(0 1):S93-103. doi: 10.1097/QAD.0000000000000039.

  • Wall KM, Vwalika B, Haddad L, Khu NH, Vwalika C, Kilembe W, Chomba E, Stephenson R, Kleinbaum D, Nizam A, Brill I, Tichacek A, Allen S. Impact of long-term contraceptive promotion on incident pregnancy: a randomized controlled trial among HIV-positive couples in Lusaka, Zambia. J Acquir Immune Defic Syndr. 2013 May 1;63(1):86-95. doi: 10.1097/QAI.0b013e31827ee19c.

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesAcquired Immunodeficiency Syndrome

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 SymptomsSlow Virus Diseases

Study Officials

  • Susan Allen, MD, MPH

    Emory University, Rollins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 21, 2003

First Posted

August 25, 2003

Study Start

January 1, 2002

Last Updated

June 29, 2007

Record last verified: 2005-09

Locations