Preventing Unplanned Pregnancies in HIV Infected Zambian Couples
Family Planning Promotion to Prevent Unplanned Pregnancies in HIV Infected Zambian Couples
調査の概要
状態
詳細な説明
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.
研究の種類
入学
段階
- 適用できない
連絡先と場所
研究場所
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Lusaka、ザンビア
- Zambia Emory HIV Research Project
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:独身
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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pregnancy
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協力者と研究者
捜査官
- 主任研究者:Susan Allen, MD, MPH、Emory University, Rollins School of Public Health
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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