Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067522
Status:
UNKNOWN
Last Update Posted:
2007-06-29
First Post:
2003-08-21
Brief Title:
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 worlds 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 360000 AIDS orphans in Zambia a country of 9 million people and 35000 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 HIVSTD 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
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 HIVSTD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD040125-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HD040125-01A1 |