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Preventing Unplanned Pregnancies in HIV Infected Zambian Couples

Primary Purpose

Pregnancy, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
User-independent contraception program
Future Planning Perspectives program
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Family Planning, Sexually Transmitted Diseases, HIV, Africa, Zambia, AIDS, Contraception, HIV Prevention

Eligibility Criteria

16 Years - 38 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zambia Emory HIV Research Project

Outcomes

Primary Outcome Measures

pregnancy

Secondary Outcome Measures

Full Information

First Posted
August 21, 2003
Last Updated
June 28, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00067522
Brief Title
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples
Official Title
Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, HIV Infections
Keywords
Family Planning, Sexually Transmitted Diseases, HIV, Africa, Zambia, AIDS, Contraception, HIV Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
5000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
User-independent contraception program
Intervention Type
Behavioral
Intervention Name(s)
Future Planning Perspectives program
Primary Outcome Measure Information:
Title
pregnancy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Allen, MD, MPH
Organizational Affiliation
Emory University, Rollins School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zambia Emory HIV Research Project
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24088689
Citation
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.
Results Reference
derived
PubMed Identifier
24098692
Citation
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.
Results Reference
derived
PubMed Identifier
23202814
Citation
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.
Results Reference
derived

Learn more about this trial

Preventing Unplanned Pregnancies in HIV Infected Zambian Couples

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