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Preventing Unplanned Pregnancies in HIV Infected Zambian Couples - Article


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Contraception

Condom; Condoms




Clinical Trial: Preventing Unplanned Pregnancies in HIV Infected Zambian Couples

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition Treatment or Intervention
Pregnancy
HIV Infections
 Behavior: User-independent contraception program
 Behavior: Future Planning Perspectives program

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  5000

Study start: January 2002

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.

Eligibility

Ages Eligible for Study:  16 Years   -   38 Years,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


Zambia
      Project ZUHRP, Lusaka,  Zambia; Recruiting
Andrea von Lieven, RN   zuhrp@hotmail.com 
Susan Allen, MD, MPH

Study chairs or principal investigators

Susan Allen, MD, MPH,  Principal Investigator,  University of Alabama   

More Information

Study ID Numbers:  HD40125; 1R01HD40125-01A1
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  August 21, 2003
ClinicalTrials.gov Identifier:  NCT00067522
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: October 3, 2005
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