Discontinuation of HIV Pre-Exposure Prophylaxis among people in serodifferent relationships: Findings from a programmatic surveillance study within a large-scale HIV program in Nigeria

doi:10.21203/rs.3.rs-3295919/v1

BACKGROUND: As Oral PrEP scales across countries, more information about uptake, use pattern and client preference emerge from pilots, demonstration studies and national programmes. The findings are useful for refining service provision and providing learnings on how oral PrEP and other prevention products or methods can be effectively incorporated into routine health services. Our study examines factors associated with discontinuation of PrEP across two large scale programs in Nigeria to present findings representative of real-world programmatic implementation.

METHODS: Through programmatic surveillance of program implementation data from two large-scale HIV projects in Nigeria, we explored early discontinuation of PrEP and associated factors among HIV-negative individuals who initiated PrEP between January 2020 and July 2021 using multivariable logistic regression.

RESULTS: Of 26,325 HIV-negative individuals who started PrEP, 84% (22,034) discontinued PrEP within the first month. Factors associated with early discontinuation of PrEP were commencing oral PrEP in the community, being unmarried, engaging in high-risk sexual behaviour, and inconsistent use or non-use of condoms.

CONCLUSION: Early discontinuation of PrEP was high, especially for individuals who commenced in the community and reported marital status as “never married”. It was also high among individuals who reported inconsistent use or non-use of condoms. We recommend the strengthening of follow-up counselling to re-assess risk determination, especially between initiation and the first follow-up visit within the health facilities as well as the community-based distribution sites.

In 2015, the World Health Organization (WHO) released guidelines recommending Pre-Exposure Prophylaxis (PrEP) as a prevention measure to people at substantial risk of HIV infection¹. Since then, the global strategy to reach “zero new infections” has included combination prevention which entails the use of behavioural, biomedical, and structural methods.^2,3 Oral PrEP is recommended for key populations, such as men who have sex with men and sex workers; it is also recommended as an option for further decreasing the chances of infections amongst heterosexual sero-different couples.⁴ Since 2015, a growing number of countries have adopted WHO recommendations on PrEP into national guidelines, and oral PrEP has become available through pilot projects, implementation studies, and national programmes⁵. In 2021, approximately 1.6 million persons received PrEP at least once globally⁶. In Nigeria, Oral PrEP was included in the National HIV/AIDs Prevention, Care, and Treatment guidelines as a biomedical prevention method in 2020⁷ and since then over 170,000 persons have initiated PrEP.⁸

As Oral PrEP scales across countries, more information about acceptability, uptake, use pattern and client preferences has emerged from pilots, demonstration studies and national programmes. These findings are useful for refining service provision and providing learnings on how oral PrEP and other prevention products or methods can be effectively incorporated into routine health services. A significant finding across many studies and programmes is that PrEP users discontinue oral PrEP within 1 to 3 months, and continuation rates are low^9–12. Researchers have investigated client-, provider- and system-level perspectives to understand factors that affect oral PrEP continuation; studies done in Eswatini, Kenya, South Africa, US and Uganda highlight reasons such as stigma-related discomforts with accessing PrEP at ART clinics, issues around inconvenient clinic locations or operating hours, long wait times, and short refill dates^13–15. Client-level factors include changes to self-perceived HIV risk, side effects¹⁶, daily pill burden^9,14, concealing pills from partner or partner’s insistence to discontinue pills^17,18. McGrory et al coalesced lessons from seven demonstration studies done in Nigeria which show that some clients start, discontinue and restart PrEP by personally gauging periods of perceived HIV risk¹⁹. As similar findings emerge, HIV prevention experts call for PrEP use to be viewed more cyclically with considerations for variable risk and prevention method switching²⁰. Current indicators for oral PrEP measure the number of individuals newly initiated on PrEP, seroconversion rates and PrEP continuation rates²¹ and does not account for discontinuous use patterns and effectiveness during periods of use.

To improve oral PrEP service delivery and draw lessons for introduction of new near-market HIV prevention products, there are calls for learnings that reveal opportunities, close program design gaps and unearth challenges in through PrEP provision especially in real-world settings^13,22. Our study, which examined factors associated with discontinuation of PrEP across two large scale programs in Nigeria, presents findings based on programmatic data. The findings represent real-world implementation which can be used to improve program design and support policy makers to anticipate needs of future PrEP programs.

Study design

Surveillance was conducted using routine program data collected from January 2020 to July 2021 in Akwa-Ibom and Cross River States of Nigeria within the context of two large-scale HIV projects. This type of study design typically relies on routine public health data analyses to inform future prevention activities within a population.^23,24

Setting

In 2018, Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS) showed that national prevalence had dropped to 1.4% prevalence of HIV nationally, but, Akwa Ibom and Cross River State had prevalence higher than the national prevalence at 5.5% and 2.2%²⁵. Thus, the United States Agency for International Development (USAID) through the Strengthening Integrated Delivery of HIV/AIDS Services (SIDHAS) and Meeting Targets and Maintaining Epidemic control (EpiC) projects launched the HIV surge implementation in Akwa Ibom State and Cross River based on the states’ epidemic dynamics^26,27. The HIV Surge implementation entailed massive community case finding and treatment saturation in line with epidemic drivers through tertiary, secondary, private-for-profit, primary health facilities, community pharmacies, and community ART management (CAM) teams²⁸. CAM teams were linked to health facilities in a hub-and-spoke model for resupplies and reporting, provided comprehensive ART services within the communities to clients who are unable or unwilling to go to health facilities, with clinicians providing clinical supervision. It was within this context that oral PrEP implementation was introduced in 2020 as part of efforts to curb rising new HIV infections. The services were provided through the same community-based and health facility delivery models that provided HIV testing and treatment services; oral PrEP was offered to partners of index clients and high HIV-risk individuals identified at both facility service delivery points and community-based HIV testing services.

PrEP Service Provision and Implementation

The priority population within these projects for provision of PrEP were HIV-negative partners of index clients and other individuals identified as “at-high-risk” of HIV during counselling and testing at both health facilities and within supported communities. This analysis was conducted among a cohort of individuals who initiated PrEP between January 2020 and July 2021. Most PrEP users included in the study were identified during index case counselling and partner testing where service providers engage and counsel serodifferent[1] sexual partners on risk reduction. Other PrEP users included in the study included individuals who upon receiving information about PrEP, either at the facility or in the community, expressed their need for PrEP services. Following the receipt of an HIV negative test result, the individual was enlisted for possible PrEP initiation.

Patient Monitoring and Follow-up

On enrollment, the PrEP users described in this study were provided with a 1-month refill and asked to return one-month post-initiation for a follow-up visit. Screening tests, assessments for adverse drug reactions, and counselling were provided at the one month follow up visit, the individuals were also asked to reach out to the health facility or community-based team in the event of an adverse drug reaction. Additional follow-up visits were scheduled quarterly (30, 90, 120, 180 days etc.). At all visits, providers counseled on risk reduction for HIV and other sexually transmitted infections, advocated for condom use alongside the use of PrEP, conducted HIV testing and screening for renal function. Providers halted PrEP to clients who seroconverted, had severe adverse effects, or failed renal function screening. After initiating PrEP, users’ follow-up status was categorized in the Medical Records as either “ongoing use” or “discontinued PrEP”. A person was said to have discontinued PrEP when the individual declines further refill of PrEP or did not return for additional PrEP refill on their appointment.

Data collection and management

Before analysis, de-identified data for the cohort of persons who had started PrEP between January 2020 and July 2021 were extracted from the Lafiya Management Information System (LAMIS), one of the national electronic medical records (EMR) systems. The LAMIS data contained client’s socio-demographics, status of taking PrEP, as well as indications for taking PrEP. As part of internal quality control measures, data were cleaned weekly to ensure optimum data quality, this entailed but is not limited to the mop-up of missing data.

Study outcomes

The primary outcome measure was early discontinuation of PrEP by the one-month follow up visit post initiation. In this study, early discontinuation was defined as clients who did not return for a refill visit one month after initiating PrEP.

Data analysis

Descriptive statistics such as proportion, median, and interquartile range were used to summarize participants’ characteristics. Pearson’s chi-square test was used to examine associations between socio-demographic characteristics and PrEP discontinuation. We used multivariable logistic regression to investigate associations between independent variables and PrEP discontinuation. Bivariate analysis was conducted on independent variables and those significantly associated with PrEP discontinuation at p<0.10 were entered into multivariable model. Independent variables considered were age, sex, educational status, occupation, marital status, initiation setting and indications for initiating PrEP. Variables with p-value <0.05 were considered as associated factors.

Ethics

This study was reviewed by Family Health International (FHI 360) Office of International Research Ethics (OIRE) and given a non-research determination (Protocol no.:1778379-1). Informed consent was not required as no people were interviewed for this study. Authors had no access to identifiable data of clients included in this study.

[1] their sexual partner was HIV infected and they were not.

From January 2020 to July 2021, 26,325 HIV-negative individuals in program-supported facilities and community-based distribution sites started PrEP. Of these, more than half (54%) were enrolled in program-supported health facilities, while 46% were enrolled at community-based distribution sites. Median age was 31 years (IQR: 27-38), 61% were males, 54% never married, 81% had at least secondary education, and 55% were unemployed (Table 1).

Providers conducted an individualized risk assessment to ascertain the indication for initiating PrEP. Majority (61%) initiated PrEP because they were in a serodifferent relationship.

Other reasons reported for starting PrEP were partner non-disclosure (11%), high risk sexual behaviour (17%), partner unwilling to undergo HIV testing (3%), inconsistent or non-use of condoms (5%) (Figure 1).

PrEP discontinuation within One Month

Over 80% (22,034) of those initiated on PrEP discontinued within one month. Individuals who initiated PrEP at community-based distribution sites (91.3%) had higher discontinuation than those who initiated in program-supported facilities (77.1%) (p<0.001). Discontinuation of PrEP was highest among never married (88%) and individuals aged 25-29 years (85.9%) (p<0.001). Regarding indication for PrEP, discontinuation of PrEP ranged from 91.7% to 71.1% and highest was among those that reported inconsistent use or non-use of condoms (91.7%) (p<0.001). Multivariable logistic regression revealed marital status, enrolment setting, and indication for PrEP initiation as significant factors associated with PrEP discontinuation. Never married clients were almost two times (aOR 1.79, 95% C.I 1.64-1.96) more likely to discontinue PrEP compared to married clients. Clients enrolled in community-based distribution sites were 2.7 times (aOR 2.72, 95% C.I 2.50-2.96) more likely to discontinue PrEP compared with those enrolled in program-supported health facilities. Clients who initiated PrEP because of high-risk sexual behaviour (aOR 1.15, 95% C.I 1.03-1.30) or inconsistent use or non-use of condoms (aOR 1.96, 95% C.I 1.59 -2.41) were more likely to discontinue PrEP than those who initiated PrEP because they were in a serodifferent relationship (Table 2).

Across these two large-scale HIV programs implemented in Nigeria, we observed that persons who commenced PrEP in the community, persons who were unmarried, persons who report engaging in high-risk sexual behaviour and persons who report inconsistent use or non-use of condoms were most likely to discontinue PrEP within one month of initiation. Both programs delivered oral PrEP through the same service delivery channels used in delivering ART in health facilities and in community-based settings. There were significantly more oral PrEP initiations in health facility settings for both programs, but more persons who initiated oral PrEP in the community-based setting discontinued early. This is an important finding because Nigeria’s adoption of differentiated delivery models for HIV services has served the country well in improving access and providing client-centric service delivery for HIV care and treatment especially in hard to reach terrains²⁷ and during the COVID-19 pandemic²⁹, however it is important to further examine the interchangeability of channels of delivery between HIV treatment and prevention. The need of a PrEP user is different from a that of a PLHIV so while the existing community-based structures serves the ART care continuum effectively; it is important to understand those needs and adapt community-based service provision or other differentiated delivery models to suit the provision of HIV biomedical prevention.

The point above also begs the questions that arises around PrEP use patterns and current PrEP counselling that support long-term use. In treatment, the goal is to achieve near perfect adherence on ART to achieve viral suppression; also, ART care and support systems are built to support clients on life-long treatment. Imperfect use of PrEP have been studied and findings reveal significant impact on reducing new infections at the population-level^12,30,31 and causing a shift towards adherence at times of risk; this is known as Prevention-Effective adherence^31,32. Our study further buttresses the call to shift from reporting PrEP use by perfect adherence for prolonged periods of time to seeking measures that require users to be adherent only during periods of risk exposure when required³². Counselling at both health facility and within the community-based settings at initiation should integrate continued willingness to use PrEP and the development of a tentative timeline for when PrEP use is most likely to stop and possibility of re-start if risk is re-introduced. Discontinuations can therefore be seen as the end of a successful short term intervention rather than an interruption.³³

In this study we noted that the absence of a formal relationship status was an influencing factor in PrEP discontinuation considering that the highest number of individuals who were reported to have stopped PrEP were “never married”. Persons who reported as “never married” were almost two times more likely to discontinue PrEP within one month of initiation compared to users who reported as “married”. However, it is important to note that the only classifications provided for relationship status in both projects’ medical records are: “married”, “previously married” or “never married”. Hence it is possible that these might have limited the range of options that exist in sexual relationship statuses, for instance, some couples may be habitual sexual partners but not married. Accounting for informal sexual relationships is important when designing programs and when training providers and counsellors. Studies in both the US and Tanzania note that lack of a formal relationship status, age, and sex³⁴, especially being young and female³⁵ raises issues around provider biases related to social mores in the provision of PrEP. Therefore, broadening definitions for sexual relationship status in counselling and providing prevention services could be helpful to address issues around stigma in service provision and remove barriers in access and service delivery especially for single, unmarried young women.

A key success of the program was the ability to identify individuals who reported engaging in high-risk sexual behavior and persons who do not use condoms consistently to provide them with oral PrEP, however, this group had the highest discontinuation rates. A limitation of this study is the inability to fully ascertain the reasons why beneficiaries in this group discontinued as both projects had passive mechanisms for following up with individuals placed on PrEP. Within the programs, the most robust interactions with beneficiaries happen at the initiation of the intervention hence it is important to acknowledge and inform PrEP users that PrEP is not a life-long intervention. This will provide roman opportunity to consider and plan with individuals about potential use patterns, perceived risk at time of initiation and possible endpoints of the intervention. PrEP discontinuation can then be seen as the successful endpoint of the intervention with room provided to clients to restart if they determine that their risk status has changed.

Early discontinuation of PrEP was high, especially for individuals who commenced in the community, and never married. It was also high among individuals who reported inconsistent use or non-use of condoms. It is recommended that PrEP services should be strengthened with robust counselling around use patterns and perceived risk at initiation and at every subsequent follow-up visit. PrEP discontinuation can be seen as the successful endpoint of intervention if preceded by adequate counselling for risk determination. We also recommend broadening definitions and language for sexual relationship status other than marital status in counselling and prevention service provision to shape provider communication and support for individuals needing and using PrEP services especially for single, unmarried young women. Further exploration on user perspectives around reasons for discontinuation and perceived HIV risk is important to generate useful insights into preferences and behaviours around prevention. We conclude that it is important to explore measures that account for non-continuous use of PrEP, depending upon use pattern and associated risk.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Table 1 Socio-demographic characteristics of individuals initiated on PrEP in Akwa Ibom and Cross River States of Nigeria (January 2020 – July 2021)

Female (N=10,214)

Number (%)

Male (N=16,111)

Number (%)

Total (N=26,325)

Number (%)

State

Akwa Ibom

Cross River

8,347 (81.7)

1,867 (18.3)

12,825 (79.6)

3,286 (20.4)

21,172 (80.4)

5,153 (19.6)

PrEP Initiation setting

Health Facilities

Community-based distribution sites

5,610 (54.9)

4,604 (45.1)

8,489 (52.7)

7,622 (47.3)

14,099 (53.6)

12,226 (46.4)

Age category (years)

15-24

25-29

30-34

35-39

≥40

Median age (IQR)

2,165 (21.2)

2,986 (29.2)

2,325 (22.8)

1,478 (14.5)

1,260 (12.3)

29 (25-35)

1,552 (9.6)

3,286 (20.4)

3,819 (23.7)

2,969 (18.4)

4,485 (27.8)

33 (28-40)

3,717 (14.1)

6,272 (23.8)

6,144 (23.3)

4,447 (16.9)

5,745 (21.8)

31 (27-38)

Education* (N=23,979)

None

Primary

Secondary

Post-secondary

470 (5.1)

1,309 (14.1)

6,340 (68.3)

1,161 (12.5)

804 (5.5)

2,020 (13.7)

9,905 (67.4)

1,970 (13.4)

1,274 (5.3)

3,329 (13.9)

16,245 (67.8)

3,131 (13.1)

Marital status

Never married

Married

Previously married

5,854 (57.3)

4,261 (41.7)

99 (1.0)

8,446 (52.4)

7,538 (46.8)

127 (0.8)

14,300 (54.3)

11,799 (44.8)

226 (0.9)

Employment status *

(N=24,095)

Employed

Unemployed

Student

3,158 (33.9)

5,212 (56.0)

942 (10.1)

5,801 (39.2)

8,023 (54.3)

959 (6.5)

8,959 (37.2)

13,235 (54.9)

1,901 (7.9)

*Complete data analyzed

Table 2: Factors associated with early discontinuation of PrEP among Users in Akwa Ibom and Cross River States of Nigeria (January 2020 – July 2021)

Characteristic

N

Discontinued PrEP within one month

n (%)

OR (95% C.I)

P-value

AOR (95% C.I)

P-value

Overall

26,325

22,034 (83.7)

State

Akwa Ibom

Cross River

21,172

5,153

17,819 (84.2)

4,215 (81.8)

1

0.85(0.78-0.92)

<0.001

1

0.69 (0.63-0.75)

<0.001

Setting

Health Facilities

Community based distribution sites

14,099

12,226

10,873 (77.1)

11161 (91.3)

1

3.11 (2.89-3.35)

<0.001

1

2.72 (2.50-2.96)

<0.001

Sex

Male

Female

16,111

10,214

13,470 (83.6)

8,564 (83.9)

1

0.98 (0.92-1.05)

0.61

1

0.96 (0.88-1.04)

0.28

Age group

15-24

25-29

30-34

35-39

≥40

3,717

6,272

6,144

4,447

5,745

3,165 (85.2)

5,390 (85.9)

5,221 (85.0)

3,685 (82.9)

4,573 (79.6)

1

1.07 (0.94-1.20)

0.98 (0.75-0.95)

0.84 (0.75-0.95)

0.68 (0.61-0.76)

0.28

0.82

0.1

<0.001

1

1.10 (0.96-1.26)

1.13 (0.98-1.30)

1.14 (0.98-1.32)

1.08 (0.93-1.25)

0.19

0.09

0.29

Education*

None

Primary

Secondary

Tertiary

1,274

3,329

16,245

3,131

1,059 (83.1)

2,784 (83.6)

13,933 (85.8)

2658 (84.9)

1

1.04 (0.87-1.23)

1.22 (1.05-1.43)

1.14 (0.96-1.36)

<0.001

0.68

0.14

1

0.99 (0.83-1.21)

0.95 (0.79-1.14)

1.03 (0.88-1.21)

0.99

0.58

0.73

Marital status*

Married

Never married

Previously married

11,799

14,300

226

9,262 (78.5)

12,583 (88.0)

189 (83.6)

1

2.01 (1.88-2.15)

1.40 (0.98-1.99)

<0.001

0.06

1

1.79 (1.64-1.96)

1.02 (0.71-1.48)

<0.001

0.90

Occupation*

Unemployed

Employed

Student

13,235

8,959

1,901

10,993 (83.1)

7,785 (86.9)

1,724 (90.7)

1

1.35 (1.25-1.46)

1.99 (1.69-2.33)

<0.001

1

1.48 (1.37-1.61)

1.66 (1.39-1.98)

<0.001

Indication for PrEP

Serodifferent relationship

Inconsistent use or non-use of condom

Reports high-risk sexual behaviour

Partner non-disclosure

Partner unwilling to undergo HIV testing

Others

16,127

1,393

4,500

2,847

774

684

13,424 (83.2)

1,278 (91.7)

4,067 (90.4)

2,024 (71.1)

693 (89.5)

508 (74.3)

1

2.24 (1.84-2.72)

1.89 (1.70-2.11)

0.50 (0.45-0.54)

1.72 (1.36-2.18)

0.84 (0.69-1.03)

<0.001

0.09

1

1.96 (1.59-2.41)

1.15 (1.03-1.30)

0.97 (0.84-1.12)

1.08 (0.85-1.39)

0.95 (0.76-1.18)

<0.001

0.016

0.69

0.53

0.63

No competing interests reported.

Discontinuation of HIV Pre-Exposure Prophylaxis among people in serodifferent relationships: Findings from a programmatic surveillance study within a large-scale HIV program in Nigeria

Status:

Version 1

Abstract

Figures

Introduction

Methods

Results

Discussion

Conclusions

Declarations

References

Tables

Additional Declarations

Status:

Version 1