PregnancyNCT00067522
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples
A study testing User-independent contraception program and Future Planning Perspectives program in people with Pregnancy and HIV Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 38 years
- Conditions the study is for
- Pregnancy, HIV Infections
- What is being tested?
- User-independent contraception program and Future Planning Perspectives program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 1 siteZambia
- Study dates
- Jan 2002to not given
- Phase
- Interventional
- 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 16 to 38 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Couples with one or both partners with HIV infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, HIV Infections
- Being tested
- User-independent contraception program, Future Planning Perspectives program
- Keywords
- Family Planning, Sexually Transmitted Diseases, HIV, Africa, Zambia, AIDS, Contraception, HIV Prevention
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
User-independent contraception programBehavioural
Future Planning Perspectives programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2003 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Allen, MD, MPH, Principal investigator, Emory University, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067522
- Sponsor's protocol ID
- HD40125
- Other IDs
- 1R01HD040125-01A1
- Status last verified
- Sep 2005
- First submitted
- 21 Aug 2003
- Last updated
- 29 Jun 2007
- Results posted
- No
Publications
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.
PubMed 24098692Haddad 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.
PubMed 24088689Wall 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.
PubMed 23202814
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples
- ClinicalTrials.gov ID
- NCT00067522
- Acronym / sponsor ID
- HD40125
- Conditions
- Pregnancy, HIV Infections
- Keywords
- Family Planning, Sexually Transmitted Diseases, HIV, Africa, Zambia, AIDS, Contraception, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jan 2002
- First posted
- 25 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Couples with one or both partners with HIV infection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| User-independent contraception program | Behavioural | – |
| Future Planning Perspectives program | Behavioural | – |
Primary outcome
pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2007.
- Derived from this study: PubMed 24098692Wall 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.
- Derived from this study: PubMed 24088689Haddad 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.
- Derived from this study: PubMed 23202814Wall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Allen, MD, MPH principal investigator
Emory University, Rollins School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing User-independent contraception program and Future Planning Perspectives program in people with Pregnancy and HIV Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Zambia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2007. 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 Zambia. 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.
Are results available for this study?
Results are not available in the source record.
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?
pregnancy. 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 NCT00067522, which also lists 3 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 29 Jun 2007; AzTrials last refreshed its copy on 26 Oct 2026.