Preventing Unplanned Pregnancies in HIV Infected Zambian Couples

June 28, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Eighty percent of the world's HIV infections are in sub-Saharan Africa. In Lusaka, the capital of Zambia, 85% of pregnant women are married and 47% are in couples with at least one HIV infected partner (26% concordant positive, 21% discordant). It will be years before short-course antivirals are widely implemented, and many children who escape infection will be left orphaned. There are 360,000 AIDS orphans in Zambia, a country of 9 million people, and 35,000 HIV infected women deliver each year.

An essential component of any HIV prevention strategy must include the prevention of unplanned pregnancies among couples with HIV. Promotion of 'dual method' contraception (condoms for HIV/STD prevention plus a longer acting method for pregnancy prevention) is ideal, but unfortunately not widely promoted. Ultimately, the prevention of unplanned pregnancy in couples with HIV can reduce pediatric HIV, AIDS orphans, and the family consequences of parental illness and death.

This study will evaluate two interventions aimed at reducing the incidence of unplanned pregnancies in HIV infected couples. The first intervention will promote more effective contraception by placing user-independent methods (IUD and Norplant) first in the educational message hierarchy (currently, family planning education highlights oral contraceptives) and employing positive message framing. The second intervention will help couples plan for the consequences of their illness and death. This will include assisting couples to work together to prepare a will, choose a guardian, and make a financial plan. By focusing on the cost of educating existing children and on the need to plan for their future care, couples are encouraged to reflect on the implications of future childbearing. The interventions will be compared with a standard family planning program with respect to impact on incident pregnancy, contraceptive choice and pattern of use, psychosocial and behavioral variables, and future planning actions. Cost-effectiveness will be determined with methods developed jointly by experts in the fields of HIV therapy in Africa and contraception.

Participants in this study will be randomized to either the user-independent contraception intervention, the future planning intervention, the contraception plus planning intervention, or the standard family planning control. Couples will be followed for 1 to 4 years. Women will have study visits every 3 months; men will have a study visit every year. The primary study outcome will be comparison of time to pregnancy across intervention groups.

Study Type

Interventional

Enrollment

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Zambia Emory HIV Research Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Couples with one or both partners with HIV infection

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Susan Allen, MD, MPH, Emory University, Rollins School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Registration Dates

First Submitted

August 21, 2003

First Submitted That Met QC Criteria

August 22, 2003

First Posted (Estimate)

August 25, 2003

Study Record Updates

Last Update Posted (Estimate)

June 29, 2007

Last Update Submitted That Met QC Criteria

June 28, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD40125
  • 1R01HD040125-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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