Pregnant and Parenting Teens Living With HIV in Lusaka, Zambia (P2G)
PREGNANT AND PARENTING GIRL PROGRAM EVALUATION
Study Overview
Status
Intervention / Treatment
Detailed Description
1.0 Introduction
Title: Program Evaluation of the Pregnant and Parenting Girls (P2G) Living with HIV: Empowering and preparing a generation of young women to achieve their life goals through a comprehensive mentorship and support package
1.1 Project Summary/Abstract
The overall objective of the Pregnant and Parenting Girls (P2G) Project is to increase resilience among pregnant and parenting girls (10-19 years) living with HIV in Lusaka. The purpose of this submission is to request approval for an evaluation of the project to measure the impact of the project interventions on the beneficiaries' resilience as well as to collect qualitative feedback on services provided by conducting In-Depth interviews with both the beneficiaries and other project stakeholders.
1.1.2 Introduction
The P2G project aims to increase resilience and improve treatment adherence among HIV positive pregnant and parenting girls aged 10 to 19 years by administering a comprehensive set of proven interventions which include formation of adolescent mother support groups, skills development, education in sexual reproductive health and rights (SRHR), mother baby pairing (Tingathe model), Girls for Girls (G4G) mentorship as well as young father involvement in pre and postnatal period. It is envisaged that these interventions will impact on resilience of the project beneficiaries including adherence to HIV treatment for both mother and baby and prevention of HIV transmission from mother to baby. The project will use trained adolescent peers to deliver the package of interventions as well as engage treatment supporters to follow up mother-baby pairs for treatment adherence and keeping clinic appointments.
1.2 Background Zambia has one of the highest adolescent fertility rates in Eastern and Southern Africa, with at least 28% girls aged 15 to 19 years having been pregnant or are mothers. Adolescent pregnancy and motherhood occur within the context of high rates of HIV in Zambia, adding a layer of complexity to the experiences of adolescent girls and their children. With a population of over 13 million, adolescents and young people aged between 15 to 24 years had an HIV prevalence of 11.6% in 2021 in Lusaka only. The prevalence and incidence of HIV among adolescent girls is associated with their vulnerability related to societal norms supportive of male superiority and sexual entitlement. Evidence shows that this leads to gender inequality and unequal power dynamics causing females to be unable to negotiate safe sex leading them to engage in risky sexual behaviours. High risk behaviours associated with HIV among adolescent girls include early sexual debut, multiple sexual partnerships, irregular condom use, intimate partner violence, intergenerational and transactional sex. According to 2015 UNAIDS data, 30% of young women aged 15-24 years in Zambia experienced physical or sexual violence from a male intimate partner.
1.3 Statement of the problem. Evidence from programs in sub-Saharan Africa highlight that HIV-infected pregnant adolescents have poorer PMTCT service outcomes, including lower PMTCT service uptake, compared to HIV-infected pregnant adults. In addition, the limited evidence available suggests that there may be higher rates of mother-to-child HIV transmission among infants of HIV-infected pregnant adolescents.
Adolescents living with HIV are also reported to have lower antiretroviral therapy (ART) adherence and viral suppression. Recent population-based surveys in three African countries (Malawi, Zambia and Zimbabwe) found that community viral load suppression among HIV-infected adolescents and young people 15-24 years was 42% compared to 63% among adults. Emerging data on the outcomes of HIV-infected pregnant adolescents indicate similar differential outcomes along the PMTCT-specific service cascade as well. This evidence highlights the need for an urgent focus on HIV prevention and treatment activities for this age group in order to improve their health and reduce HIV transmission to infants and sexual partners.
A study in Kenya found that fewer (4.8%) HIV-infected pregnant adolescents were already on ART for their own health prior to entry into antenatal care (ANC) of HIV-infected pregnant adolescents compared to 43.1% of adult women. These findings highlight the importance of ANC services as an opportunity to identify HIV-infected pregnant adolescents and rapidly initiate ART to prevent mother-to-child HIV transmission and decrease maternal morbidity and mortality.
The above evidence therefore suggests that "business as usual" within the PMTCT service cascade has not worked well for adolescent mothers. PMTCT interventions should recognize this population as a vulnerable subgroup and develop evidence-based, enhanced support strategies which address their needs. Some research work with pregnant adolescents living with HIV documents concerns about prejudicial community attitudes towards pregnancy and HIV status and poor interactions between the patient and healthcare provider. Hence, 'adolescent-friendly' pre- and post-natal services" that emphasize confidentiality, address stigma related to HIV infection and adolescent pregnancy and integrate innovative models of increasing social support need to be provided to this population.
There is currently limited evidence in the published literature describing support interventions for HIV-infected adolescent mothers, but the available data suggest that targeted psychosocial and family support interventions within the clinical or community settings may be needed to address the barriers to care experienced by HIV-infected adolescent mothers. One study from South Africa showed higher uptake of prenatal care and PMTCT interventions among married HIV-infected adolescent mothers compared to unmarried adolescent mothers living with HIV, demonstrating the importance of social support, and, in particular, partner involvement, throughout the PMTCT cascade. According to Callahan et.al., pregnant HIV-infected adolescents should also be considered a priority population for access to intensive retention interventions such as treatment supporters accompanying them through the cascade of services to ensure that barriers are effectively resolved, patient empowerment messages and financial support.
Targeted programming and strategies for adolescent mothers living with HIV are essential to reaching global goals of controlling the HIV epidemic. Given the high prevalence of both HIV infection and pregnancy during the adolescent period, a focus on optimizing comprehensively tailored services for pregnant and breastfeeding adolescents is critical to achieving elimination of mother-to-child transmission goals and ensuring HIV-infected adolescents and their families are able to live long, productive lives.
1.4 Study Rationale Multiple global initiatives including the Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) and the United Nations Children's Fund (UNICEF)'s All in Initiative have focused many resources on the protection of the SRHR of adolescents within sub-Saharan Africa to prevent HIV infection and early pregnancies but there's insufficient interventions towards adolescent girls who are already pregnant and living with HIV. Special attention is needed for this subgroup population of adolescents, and it is paramount that the prevention of mother-to-child HIV transmission (PMTCT) agenda is tailored to focus on the needs of HIV-infected pregnant adolescent girls aged 10-19 years and develop service delivery packages which address their needs as both HIV-infected adolescents and HIV-infected mothers. This group is particularly vulnerable and needs enhanced support to achieve optimal maternal and infant outcomes.
With the understanding that adolescents (ages 10-19) and youth (ages 15-24) bear a disproportionate share of the HIV burden, little is known about what combination interventions are effective for changing HIV related outcomes in this age group. The findings of this study will be the basis for establishing the most effective interventions that will promote good health and economic resilience among pregnant and parenting adolescent girls living with HIV.
1.5 Theoretical Model
To produce long term behavioural change or significant improvements among adolescents there is a need for adolescent interventions to be tailor-specific to adolescent needs whilst maintaining a holistic approach. Studies have shown that satisfaction with adolescent-centred services is associated with relationship building, comprehensiveness of interventions, empowerment and respectful engagement with adolescents. Impacting the social ecology surrounding pregnant and parenting adolescents through partner involvement, skills development, mentorship, and SRHR service provision is critical for enhancing promotive factors that have the potential to increase resilience and motivate adolescents to do well and ultimately allow their voices to be heard so that they are able to make informed decisions to achieve important everyday goals.
It is envisaged that the package of interventions in this program (skills development, mentorship, SRHR knowledge, Tingathe model, G4G mentorship, and partner involvement) will enhance resilience among the target population. Resilience refers to an individual's capacity to successfully adapt to change and stressful events in a healthy and constructive way. Resilience has been conceptualized as a dynamic process involving an interaction between both risk and protective processes that act to modify the effects of an adverse life event. In this context, resilience does not so much imply immunity to stress, but rather an ability to recover from negative events. Building skills that help to promote resilience in young people, therefore, is an important strategy in ameliorating health problems. Resilience is not necessarily an innate attribute; rather it may be best described as an adaptive process involving interactions between risk and protective factors across multiple levels of an individual's lived experience. Researchers typically categorize resilient attributes into dispositional or personal characteristics (e.g., a sense of spirituality, positive social skills, and personal efficacy), family or social characteristics (e.g., connectedness to a parent or caregiver), and environmental characteristics (such as involvement in one's community, access to health services and the presence of caring adults).
Empowerment is widely acknowledged as a process by which those who are considered vulnerable are able to increase their self-efficacy, make life-enhancing decisions, and obtain control over resources. In addition, empowerment is multi-dimensional - a woman may be empowered in one dimension or sphere (such as financially) but not in another (such as in sexual and reproductive decision-making). Most countries now recognize the importance for girls and women to become more empowered, both as a goal in itself, as well as to achieve a more gender equitable society. More recently, researchers have been assessing the contexts and mechanisms by which empowerment directly or indirectly affects various aspects of women's health. With the understanding that empowerment is associated with improved health outcomes, the P2G program has included skills development in the package of interventions for pregnant and parenting girls living with HIV.
Investigators have included the Girls for Girls (G4G) mentorship program to enhance decision making and leadership skills for the target beneficiaries. While there is no universal consensus on the definition of mentorship, mentoring is an interactive, facilitative process meant to promote learning and development. Mentorship can either be formal [generally designed for a predetermined length of time] or informal [based on good rapport and mutual attraction, which tends to develop slowly]. It occurs when a more skilled or experienced person is paired with a less skilled person with the agreed-upon goal of having the less skilled person develop specific abilities to reach long-term objectives. Adolescent mentorship has been associated with a wide range of positive outcomes, including increased confidence and self-esteem among mentored individuals compared to their non-mentored counterparts. Mentees also gain more knowledge, experience less stress and conflict, are more satisfied with their achievements, and are more likely to speak out on matters that affect their health. The G4G program comprises a curriculum that has five main sessions focusing on communication, negotiation and leadership. G4G has used this curriculum in more than 5 countries including Zambia. For this component, investigators partnered with the G4G Project, an organisation which mentors young girls to lead, speak up, negotiate, and navigate power relationships. Bringing together insights from established women leaders and a global network, G4G uses "mentorship Circles" - local learning and support communities- for small groups of promising young women, led by a mentor.
Investigators have included SRHR knowledge because despite the availability of SRH services, adolescent girls continue to face several unmet needs related to SRH as they experience barriers to accessing these services. These obstacles mainly exist because of the lack of, or inadequate age-appropriate information tailored for their easy assimilation and understanding. Adolescent girls face personal barriers such as shyness, ignorance, cost, inconvenient time, location of youth-related services, and fear of judgmental behavior of healthcare providers. Therefore, enhanced SRHR knowledge delivered by peers is likely to improve adolescent girls' desire to access SRHR services. It is important to ensure that these services are, accessible, appropriate, and acceptable, and they are provided by trained health professionals preferably of peer age.
To improve retention in care for our target population, investigators have adopted the Tingathe model from Malawi. The Tingathe model uses community volunteers to track mother-baby pairs until the infant is 24 months old. It proved to be highly successful in Malawi as retention in care improved from 32% up to 78%. Loss to follow-up is a major challenge in the PMTCT program. Thus, to eliminate paediatric HIV through prevention of mother to child transmission requires close monitoring of the mother-baby pair at different intervals from birth until the baby is 24 months with final (HIV test) outcome documented. Exposed babies are tested for purposes of establishing their HIV status at birth, at 6 weeks, at 6 months, at 9 months, at 18 months, and finally at 24 months. Generally, there is good attendance of mother-baby pair up to 6 months but there is a marked drop at 9 months onwards with over 50% infants with undocumented final outcome at 24 months. With the Tingathe model, the investigators will use community volunteers to track mother-baby pairs over a period of one year or until the baby is 24 months until final outcome is documented.
The project's reliance on peer-led service provision to deliver the comprehensive package of interventions in this program is based on the theory that the passage of sensitive information is easier between people of the same age group. Similarly, based on the theory of social awareness, peers tend to imitate the behavior of someone they consider a role model. International research studies show that peer education can make a valuable contribution to the prevention of risky behaviors. The purpose of the peer education method is thus to enhance the knowledge, attitude, and skills of adolescents and young adults, towards the promotion of healthy behaviours.
1.6 Significance of the Study
The results of the project will establish the impact of skills development, adherence support to HIV treatment, and baby-mother pairing (Tingathe) on HIV infected pregnant and parenting adolescents enrolled in the P2G programme. The evaluation of this program will generate useful information on the effectiveness of the provision of a comprehensive package of adolescent friendly services in improving HIV treatment adherence and PMTCT. Based on outcomes, it will be possible to recommend best practices for adolescent friendly HIV services in order to improve the quality of HIV services delivered to young people particularly adolescent mothers living with HIV.
1.7 Research Questions
The study will address the following questions:
- How has engaging in a skill empowerment program improved the self-efficacy and or economic livelihood of young mothers 18-20 years?
- How has the Tingathe intervention model improved PMTCT in adolescent mothers 18-20 years?
- How effective is the inclusion of male partner involvement in improving the ART adherence in adolescent mothers 18-20 years?
- What influence has the G4G mentorship program and SRHR education had on young mothers' confidence in making SRH decisions?
1.8 Aim/goal of the study (General Objective) Aim: To improve resilience among pregnant and parenting girls (10-19 years) living with HIV in Lusaka.
Objective 1: To improve self-efficacy (resilience) among adolescent mothers living with HIV.
Young mothers recruited during this period will be actively engaged in the program interventions. This means that young mothers will be involved in regular group sessions and receive skills development in bead making, basket making, decorative bottles, handbags, bracelets and trinkets, reusable pads, hair plaiting, fritter making, face make-up, etc. and trained in financial literacy as well as link to markets to sell art crafts made. Beneficiaries will also be grouped into mentorship circles for the G4G mentorship sessions which will be focused on mentorship on leadership, communication, and negotiation skills. It is envisaged that at the end of these sessions young girls will be able to lead, speak up, negotiate and gain confidence with a more positive outlook on their hopes and aspirations. To measure resilience both before and after administering the package of interventions to pregnant and parenting girls, the project will use the CYRM-28 (see attached tool).
Objective 2: To improve retention in care and viral suppression for both adolescent mothers and their babies.
Utilizing the proven Tingathe model to manage the adolescent mother-baby pairs and strengthen adherence to HIV treatment, the program will assign treatment supporters to all breast-feeding mothers recruited. HIV exposed babies and their mothers will be tracked over the project period or until the baby is 24 months old with the final outcome of baby HIV status documented. Treatment supporters will be recruited from communities where the positive pregnant mothers come from and tracking of adolescent mothers would commence from time of birth of babies or from initial engagement in the program until the child is 24 months. Treatment supporters will ensure that mother-infant pairs receive all necessary PMTCT services. They will follow their clients at their homes and at health centers until confirmation of definitive HIV-uninfected status after cessation of breastfeeding or successful ART initiation for HIV-infected infants. Adolescent mothers viral load testing will also be tracked at regular intervals at per national guidelines for HIV positive clients. Treatment supporters will actively follow up adolescent mothers to ensure no missed appointments and assist fast track them when they visit the health facility. Young fathers will be encouraged to escort their partners and benefit from the skills development activities as well as receive information and education on SRHR, GBV, and fatherhood.
Objective 3: To improve SRHR knowledge for adolescent mothers living with HIV. Pregnant and parenting girls aged between 10-19 years and living with HIV will be recruited into support groups at the health facilities. They will then be educated on SRHR using the Comprehensive Sexuality Education curriculum for out of school adolescents and young people that was developed by the Ministry of Sport Youth and Child Development and is currently being implemented in various districts by the Ministry of Health. The CSE curriculum focuses on sexuality, gender, rights, and related life skills as well as new information on HIV and sexual reproductive health. The curriculum takes 10 days to complete and trained Peer Educators will deliver the content.
3.6 Data management and storage
Qualitative IDIs, KIIs and FGDs will be audio recorded on an audio recording device for subsequent transcription. The note-taker will take interview notes to ensure no information is lost in the event of technological failure. The interviewer will take field notes to provide context. While in the field, audio-recorders and notebooks will be held on the note-taker's person.
All audio recordings will be saved on a password protected laptop. The audio recordings will be transcribed and anonymized by replacing individual names, dates, and places with a qualitative unique identifier number. Access to the raw audio files will be restricted to authorized users and stored on the CIDRZ server. Final transcripts will be checked for accuracy against original notes and recordings and saved in the same location as their associated audio files. Recordings on the voice recorder will be deleted soon after they have been transferred to the study laptop. Following study completion as explained above, data will be stored for 3 years at CIDRZ.
Quantitative component For routine data collection, trained study staff will enter data into District Health Information system 2 (DHIS2) on handheld study tablets, across the 12 facilities. Upon completion, study staff will review each entry on the tablet to ensure completeness and quality control and regularly upload to the central CIDRZ server. The study handheld tablets are password protected for data's security purposes. Data will only be accessible to study staff members and the analysis team. In the wake of the study findings, data will be stored for 3 years to the central CIDRZ server.
3.7 Data Analysis Qualitative: IDI's and FGDs will be analyzed through an inductive and deductive process where major and minor themes will be identified as they emerge as well as from existing evidence. Once data collection begins, transcripts will be reviewed as soon as they become available. The qualitative analysis software, Dedoose, will be used to help organize and code transcripts. The P2G model will be used to explain the impact and motive towards changed behavior that influence SRHR decisions and resilience.
Quantitative: Descriptive analysis will be used to describe the demographic makeup of the participants. The primary outcome is resilience defined using adapted CYRM-28 standard. The primary analysis will compare mean resilience among adolescents living with HIV at baseline and endline using student t test.
3.8 Ethics considerations The evaluation protocol will be reviewed and approved for ethics by the University of Zambia Biomedical Review Ethics Committee (UNZA BREC) and the National Health Research Authority (NHRA). The evaluation carries minimal risk and investigators have considered ethical issues as below.
Voluntary participation: Consent will be obtained in the participant's choice of English, Nyanja, or Bemba prior to participating in the study. There will be no penalty for participants who withdraw from the evaluation. Consent will be sought from the participant that is already enrolled in the program. Potential participants, who are able to demonstrate adequate comprehension and wish to participate will sign a consent form. Researchers will be trained to master active listening and asking open-ended questions free of prejudice. In addition, they will be trained on rapport building and authentic engagement to understand what is being said, clarifying ambiguous statements, and constructing appropriate follow-up questions. Participation will be voluntary and eligible participants will read a study information sheet on the introduction, purpose of the study, time required of them, assurance of confidentiality, and procedures.
Privacy and confidentiality: IDIs, KIIs and FGDs will be conducted at the YFS and interviewers will be trained in ethics and protection of human subjects. All research team members will be expected to sign a confidentiality agreement prior to the commencement of data collection. Participants will be allocated a unique participants identification number. These numbers will be used to identify all records relating to the participant. Data will be stored on a password protected laptop and will be identifiable by participant ID number only. Participants' identifiable data collected in the study will be stored securely and their confidentiality protected in accordance with the applicable Laws of Zambia and CIDRZ procedures.
Risks: Participants will be recruited at clinical care settings and participation in the study will not affect their ability to obtain HIV care and treatment. The risk of a confidentiality breach will be minimized by; 1) not recording individual names; 2) assure privacy for all IDIs and FGDs; 3) explain to all participants that they do not have to answer any question that they find distressing or do not want to discuss; 4) remind FGD participants to maintain group confidentiality; and 5) assure participants that dissemination of findings, reports or presentations will not disclose individual participant information at all costs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lusaka Province
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Lusaka, Lusaka Province, Zambia, 10101
- Kanyama General Hospital Youth Friendly Space (YFS) Matero General Hospital YFS George Clinic YFS Mandevu Clinic YFS Chilenje Level 1 YFS Chainda Clinic YFS Bauleni clinic YFS Mtendere Clinic YFS Chawama General Hospital YFS Chipata General Hospital YFS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HIV positive
- Adolescent girls >18 years old
- Pregnant or
- parenting a baby <2 years old
- Voluntary/informed consent
Exclusion Criteria:
- HIV Negative
- Not pregnant or parenting a child >2 years old
- Unwilling to provide consent
- < 18 years of age
- newly recruited in P2G program (less than 6 months exposure to intervention)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pregnant and Parenting teens
Young mothers and pregnant teens recruited will be engaged in the program interventions which include regular support group sessions where they receive skills development in bead making, basket making, decorative bottles, handbags, bracelets and trinkets, reusable pads, face make-up, etc. and in financial literacy.
Beneficiaries are also grouped into mentorship circles for the G4G mentorship sessions which is focused on leadership, communication, and negotiation skills.
It is envisaged that at the end of these sessions (curriculum of 12 G4G sessions) young girls are able to lead, speak up, negotiate and gain confidence.
Treatment supporters are assigned to all breast-feeding teen mothers to ensure that mother-infant pairs receive all necessary PMTCT services.
HIV exposed babies and their mothers are tracked over the project period or until the baby is 24 months old with the final HIV status outcome recorded.
SRHR education is also provided through peer educators.
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The P2G project aims to increase resilience and improve treatment adherence among HIV positive pregnant and parenting girls aged 10 to 19 years by administering a comprehensive set of proven interventions which include formation of adolescent mother support groups, skills development, education in sexual reproductive health and rights (SRHR), mother baby pairing (Tingathe model), Girls for Girls (G4G) mentorship as well as young father involvement in pre and postnatal period.
It is envisaged that these interventions will impact on resilience of the project beneficiaries including adherence to HIV treatment for both mother and baby and prevention of HIV transmission from mother to baby.
The project is using trained adolescent peers to deliver the package of interventions as well as engage treatment supporters to follow up mother-baby pairs for treatment adherence and keeping clinic appointments.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Building Resilience
Time Frame: From participant enrolment to completion of post-intervention resilience assessment after receiving the comprehensive support package. A participant qualified for resilience assessment if they have been exposed to intervention for minimum of 6 months.
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A mixed methods study using a sequential design of qualitative and quantitative indicators at baseline and end line.
A quantitative self- administered paper-based survey consisting of seventeen questions to assess the resilience levels and self-efficacy, using the adapted Child Youth Resilience Measure (CYRM-28) standard.
Qualitative methods used at baseline and endline to understand SRHR knowledge level and practices on treatment and adherence, and the level of male partner involvement in perinatal clinic visits.
To collect this qualitative data, the study uses Focus Group Discussions and In-Depth Interviews with adolescent mothers living with HIV/AIDS and young fathers as well as Key Informant Interviews (KII) with Adolescents focal point person and Caregivers.
For routine data collection, District Health Information system 2 (DHIS2) will be used by trained study personnel.
This design aims to provide an In-depth understanding of resilience, treatment adherence, and PMTCT.
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From participant enrolment to completion of post-intervention resilience assessment after receiving the comprehensive support package. A participant qualified for resilience assessment if they have been exposed to intervention for minimum of 6 months.
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Collaborators and Investigators
Investigators
- Study Chair: Anjali SHARMA, PhD, Centre for Infectious Disease Research in Zambia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- HIV Infections
- HIV Seropositivity
Other Study ID Numbers
- P2G Program Evaluation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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