- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00067522
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples
Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Lusaka, Zambia
- Zambia Emory HIV Research Project
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
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pregnancy
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Susan Allen, MD, MPH, Emory University, Rollins School of Public Health
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HD40125
- 1R01HD040125-01A1 (U.S. NIH-stipend/kontrakt)
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