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Retention of Women in the PMTCT (Prevention of Mother-to-child Transmission of HIV)

2018年10月9日 更新者:Augustine Ndaimani、University of Zimbabwe

Retention-in-care of Women in the Elimination of Mother-to-child Transmission of HIV (eMTCT) Option B Plus Program in Mashonaland East, Zimbabwe: a Mixed Method Study

EXECUTIVE SUMMARY RESEARCH QUESTION TO BE ADDRESSED BY THIS PROPOSAL What are the factors associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT (elimination of mother-to-child transmission of HIV) sites with high retention-in-care compared to eMTCT sites with low retention in care? Hypotheses Null hypothesis H0: The attributable rate of low retention-in-care of women in the eMTCT program at eMTCT sites equals zero.

Alternative hypothesis HA: The attributable risk of low retention-in-care of women in the eMTCT program at eMTCT sites is not equal to zero.

RATIONALE FOR RESEARCH There is poor retention of women along the PMTCT (prevention of mother to child transmission of HIV) cascade. Retention in eMTCT refers to documented regular participation of the pregnant woman, confirmed HIV positive, together with her child or children not yet confirmed as HIV-positive, in all prescribed activities aimed at preventing transmission of HIV from her to the child, and scheduled or unscheduled HIV-care related visits, measured during or at the end of care. It results in uninterrupted supply of ART (antiretroviral therapy). Retention in PMTCT ranges between 10.6% and 76.5% in other countries. In Zimbabwe it was found to drop from 83% at second pick up of antiretroviral drugs to 45% at fourth pick up of antiretroviral drugs. Poor retention in PMTCT leads to poor health outcomes in the mother and the baby. These include increased viral load, reduced CD4 count, reduced adherence to ART, emergency of drug resistant HIV strains, reduced quality of life, increased frequency of opportunistic infections, increased all-cause hospitalizations and death of women and children. HIV infection contributes to between 6 and 20% of maternal deaths. On the other hand, about 14% of all new infections are due to MTCT (mother to child transmission of HIV).

Retention in care is better at some clinics and hospitals. The purpose of the study will be to determine the factors associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT sites.

The following objectives will be addressed in the study:

  1. To assess the PMTCT Option B Plus program at selected eMTCT sites.
  2. To determine the prevalence of retention among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
  3. To determine the incidence of attrition among women enrolled in the eMTCT Option B+ program at selected eMTCT sites.
  4. To identify factors associated with variability in levels of retention-in-care of women in the eMTCT Option B+ program at selected eMTCT sites.
  5. To explore the barriers and facilitators of retention among women enrolled in the eMTCT Option B+ program.

METHODS The study is being done through a nested, embedded, mixed methods study with priority given to a prospective cohort methodology. The supplementary design is a simple descriptive qualitative design carried out through focus group discussions. A mixed methods design caters for the weaknesses in either a qualitative or a quantitative design. Hence, it is ideal in study of complex human issues such as retention in the PMTCT Option B Plus program.

In the study, 462 pregnant women enrolled for PMTCT Option B Plus will be followed up for 12 months in an open cohort. The sample size was calculated using Stata software based on a power of 0.8, a margin of error of 0.05, a design effect of 1.1 and a retention rate of 0.45. Six randomly selected eMTCT sites in Mashonaland East Province were chosen for the study. Retention rate at the sites since 2013 will be calculated. Three sites with lower retention will be considered as the exposure sites. The other 3 sites will be the unexposed sites. Option B Plus, a recently introduced and recommended PMTCT option, was meant to benefit pregnant women, in addition to their children and sexual partners. Hence, the involvement of women as participants. Four focus group discussions will also be done, with nursing mothers to ascertain the barriers and facilitators of retention in PMTCT Option B plus. Included in the study will be HIV positive pregnant and nursing women coming for PMTCT Option B Plus. Women who can communicate in English or Shona and are without psychiatric conditions will also be included. Emancipated minors, below 18 years of age will also be included. Excluded from the study will be women enrolled in PMTCT Options A or B, women with psychiatric conditions or those who are too ill to participate. The study was approved by The Medical Research Council of Zimbabwe. Signed voluntary consent is sought from participants. Data is being collected through questionnaires and audio-taped focus group discussions. Follow-up data will also be extracted from eMTCT registers at respective eMTCT sites. Data is kept in locked cabinets only accessible to the principal investigator and the supervisors.

調査の概要

状態

完了

研究の種類

観察的

入学 (実際)

468

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Mashonaland East
      • Marondera、Mashonaland East、ジンバブエ
        • Mashonaland East Province (Mutoko Hospital, Murewa Hospital, Kunaka Hospital, Nharira Hospital, Chichu Clinic, Epworth Polyclinic)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

15年~49年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

確率サンプル

調査対象母集団

The target population in the study will consist of women who are enrolled in eMTCT Option B+ program. The accessible population will be women enrolled and coming for PMTCT services at eMTCT sites in Mashonaland East Province.

説明

Inclusion Criteria:

  • women 15-49 years. On PMTCT tes and treat strategy or Option B+

Exclusion Criteria:

  • mentally unstable women or not enrolled at the study sites for PMTCT. Women enrolled in Option B Censoring - after a miscarriage, still birth, on leaving the PMTCT program and at the end of the study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

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
メジャーの説明
時間枠
Retention in care based on record review and follow up data
時間枠:One follow-up per 3-month period, up to 12 months
Missed visit count (number of missed visits), Dichotomous missed visit (more than one missed visit), Visit adherence (number of kept visits divided by the total number of scheduled visits), Four month constancy (the number of four month intervals in which the individual came for PMTCT at least once), 6-month gap (no visit in a 6-month period), HRSA HAB (Health Resources and Services administration HIV-AIDS Bureau) [2 kept visits separated by at least 90 days in a year)
One follow-up per 3-month period, up to 12 months
Attrition from PMTCT (determined through survival analysis based on Cox proportional hazards regression)
時間枠:One follow-up per 3-month period, up to 12 months
Death or loss to follow - up from PMTCT
One follow-up per 3-month period, up to 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Barriers and enablers of retention (focus group discussions)
時間枠:One focus group per week, up to 4 weeks, (total of four focus group discussions)
Perceived barriers and facilitators of retention. Focus group discussions analysed through latent content analysis)
One focus group per week, up to 4 weeks, (total of four focus group discussions)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Augustine Ndaimani, DPhil MD (Student)、University of Zimbabwe

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年11月18日

一次修了 (実際)

2017年11月30日

研究の完了 (実際)

2018年7月30日

試験登録日

最初に提出

2017年6月30日

QC基準を満たした最初の提出物

2017年7月7日

最初の投稿 (実際)

2017年7月11日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月11日

QC基準を満たした最後の更新が送信されました

2018年10月9日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • A2087

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いいえ

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