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临床试验/NCT03090802
NCT03090802已完成不适用

Re-enrolling Young South African Mothers in School as a Social Vaccine Against HIV Transmission

Drexel University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2017年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
1
主要终点
Self-report missed days in school in the past 30 days

研究概览

简要总结

This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV incidence by increasing the number of adolescent mothers who re-enroll and remain in school. The objective of the intervention is to have older mentor mothers, who themselves were pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide ongoing psychosocial support, help navigate re-admission to school, and help facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period. Our combination social protection program will enhance resilience of young adolescent mothers to facilitate their return to school and thereby reduce HIV risk. The investigators will evaluate the efficacy of the intervention using a pre-test post-test randomized controlled trial design. Participants in the intervention will receive the Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care. Those in the control arm will receive standard postpartum care. Additionally, for those participants randomized to the intervention arm, mentor mothers will use participatory visual methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last, among those participants randomized to the intervention arm and who return for their 9-month assessment, the investigators will conduct 20 in-depth interviews to understand the process of resilience development from their perspective.

Primary outcomes:

School outcomes (initial outcomes) HYP 1.1: Program participation will increase school enrollment HYP 1.2: Program participation will increase school engagement

HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP 2.3: Program participation will reduce intimate partner violence HYP 2.4: Program participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will increase retention in care

Secondary outcomes:

HYP 5: Program participation will increase peer support HYP 6: Program participation will increase familial support HYP 7: Program participation will increase school re-admission HYP 8: Program participation will increase application to the child support grant HYP 9: Program participation will increase receipt of the child support grant

详细描述

All study activities will take place in Umlazi township in eThekwini district. The township is served by one regional hospital, Prince Mshiyeni Memorial Hospital, which is the referral hospital for 17 primary health care clinics.

Participants will be involved in the study from delivery to 9 months postpartum. The intervention study will be delivered in two cohorts (n=240 per cohort). The first cohort will be enrolled beginning in May 2017. The investigators anticipate that 4 adolescent mothers will be enrolled per day based on the monthly number of adolescent deliveries at Prince Mshiyieni hospital and our own capacity. Therefore, investigators will be finished enrolling the first cohort by July 2017. The first cohort will complete the end line assessment between December 2017-February 2018.

The investigators will begin enrolling the second cohort in September 2017 and will complete enrollment by November 2017. The second cohort will complete the end line assessment between June-August, 2018. Primary outcome analysis will be complete by October, 2018.

MAMAS Intervention The investigators will roll out the program with two cohorts of adolescent mothers (n=240 per cohort); each mentor mother will work with 10 adolescent mothers per cohort. Within each cohort, there will be an intervention arm and control arm (N=240 per arm for the both cohorts). The participants of the program arm will have 15 group sessions with mentor and up to 2 home visits from 3 weeks-6 months postpartum. Investigators will use participatory visual methods (e.g., photovoice, journaling, and drawing) throughout program implementation with adolescent mothers to understand and further facilitate their process of resilience development. As one example, as part of the mentoring process, adolescent mothers may be asked to engage in reflexive journaling. Mentor mothers will ask adolescent mothers who are comfortable doing so to share excerpts from their journals in a particular group session. Through the group session, the adolescent mothers themselves will identify common barriers they are facing and will work together to overcome them. Mentor mothers will keep weekly logs documenting what was covered in the sessions; these will be abstracted as part of ongoing monitoring and evaluation.

All 480 participants will complete a baseline behavioral and biological assessment (HIV and HSV-2 testing) at 2 weeks postpartum and an additional baseline biological assessment (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia trachomatis testing) at 6 weeks postpartum. Further, all participants will receive regular postpartum and well-baby visits at 6 weeks, 10 weeks, 14 weeks and 6 months with an adolescent-friendly study nurse. During the visits, participants will complete routine assessments. At 9-months postpartum, participants will complete end line behavioral and biological assessment (HIV, HSV-2 Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia trachomatis testing).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Self-report missed days in school in the past 30 days

时间窗: 9-months postpartum

Categorical outcome (5)

Self-reported percentage of condom use while having sex in the past 30 days

时间窗: 9-months postpartum

Categorical outcome (6)

IPV in the last 30 days (WHO modified conflict tactic scale)

时间窗: 9-months postpartum

Consist of 10-items.

Results from HIV rapid test

时间窗: 9-months postpartum

Binary outcome

Results from Gonorrhea test using BD ProbeTec ET Amplified DNA Assay

时间窗: 9-months postpartum

Binary outcome

Results from Chlamydia test using BD ProbeTec ET Amplified DNA Assay

时间窗: 9-months postpartum

Binary outcome

Results from Trichomonas vaginalis test using in-house PCR

时间窗: 9-months postpartum

Binary outcome

Self-reported number of men a participant has had sex with in the past 30 days

时间窗: 9-months postpartum

Self-reported enrollment into school

时间窗: 9-months postpartum

Binary outcome

次要结局

  • Score on peer support scale (self-reported)(9-months postpartum)
  • Whether participant received the child support grant (self-reported)(9-months postpartum)
  • Whether participant applied for child support grant (self-reported)(9-months postpartum)
  • Score on familial support scale (self-reported)(9-months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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